Acetaminophen Black Box Warning by FDA

6-30-2009

Acetaminophen /Tylenol – Black Box Warning Recommended by the FDA

The FDA has recommends that the a black box warning is added to the labels of prescription pain and cold products that contain acetaminophen wich is widely known under the brand name Tylenol.

The FDA states that there is a signifigant health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products.

Because acetaminophen is important for the use of treating pain and fever they do not want to remove it from the market.

Acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.

Acetaminophen is the active ingredient in Tylenol.
It is also found in many other over-the-counter medications you can buy at the drug store and in prescription drugs your doctor prescribes:
Common names include:

  • Actifed
  • Alka-Seltzer Plus
  • Benadryl, Butalbital
  • Co-Gesic
  • Contac
  • Darvocet
  • Excedrin
  • Fioricet
  • Lortab
  • Midrin
  • Norco
  • Percocet
  • Robitussin
  • Sedapap
  • Sinutab
  • Sudafed
  • TheraFlu
  • Unisom With Pain
  • Vick’s Nyquil
  • Vick’s DayQuil
  • Vicodin,
  • Wygesic
  • Zydone

Acetaminophen in overdose can seriously damage the liver. If the damage is severe, a liver transplant may be necessary in order to save a life.

Accordning to Research, hundreds of people each year are diagnosed with acute liver failure as a result of taking acetaminophen and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.

Although researchers have found that the drug is safe if taken at recommended levels, its prevalence in a variety of pain relievers, fever reducers and cough medicines as a somewhat hidden ingredient means patients don’t realize they are taking several drugs that all contain acetaminophen.

Related:

Acetaminophen Side Effects
Acetaminophen liver injury
Class Action Lawyers
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FDA, black box, warning,labels,prescription, pain, cold ,products, acetaminophen

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Blair Robes Recall- 162,000 women’s robes recalled after 6 deaths

June 11, 2009 by Jay Genkins  
Filed under Defective Products, Recalls


Consumers are being urged to immediately stop wearing a certain type of chenille robe made by Blair LLC due to a fire hazard that is believed to have killed at least six people.

The Consumer Product Safety Commission and Blair LLC, based in Warren, Pa., on Thursday said they were issuing the second recall notice in two months after receiving reports of six deaths due to the robes catching on fire. In five of the six cases, the victims were women who were cooking at the time; three of the victims were in their 80s. The recall applied to 162,000 robes.

“CPSC urges all consumers to report any incidents or injuries involving consumer products, even after a recall has been announced,” said acting CPSC Chairman Thomas Moore. “Contact the CPSC so that we may help prevent tragic deaths or injuries like those that might be related to the Blair robes.”
CPSC and Blair initially announced their voluntary recall in April, citing three reports of the robes catching on fire, including one report of second-degree burns.

The robes, made in Pakistan, have the following item numbers: 3093111, 3093112, 3093113, 3093114, 3093115, and 3093116. They are a one-piece garment made of plush sculpted chenille, a shaped stand collar, and horizontal chenille front and back yolks and cuffs. The robes have a full-button front with seven matching button closures.

The robes were sold in Blair catalogs and on the company Web site, as well as Blair stores in Warren, Pa., Grove City, Pa., and Wilmington, Del., from January 2003 through March 2009. Consumers may return the robe to Blair and receive a refund or a $50 gift card by contacting the company at (877) 392-7095 between 9 a.m. and 9 p.m. ET Monday through Saturday, via the firm’s Web site at Blair.com/recall, or by e-mail at blairproductrecall(at)blair.com.


Baxter Infusion Pump Recall

March 12, 2009 by Jay Genkins  
Filed under Defective Products, Recalls

A Class 1 Recall of  Baxter infusion pumps by the FDA.

Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter
The Model numbers are:

  • Mono 2M8151 and 2M8153
  • CX 2M8161 and 2M8163
  • CXE 2M9161 and 2M9163

The defective Pumps were manufactured and distributed from February, 1997 through December, 2008.

The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.


Chinese Drywall Lawsuit by Florida Homeowners

Chinese Drywall Lawsuit in Florida

Florida Home owners have filed another Chinese Drywall Lawsuit.  This is the latest of four lawsuits filed so far and allege that tens of thousands of florida homes could be built with the defective Drywall from China.

Several homeowners have complained of  “rotten egg” smells coming from the drywall. Drywall is usually manufactured in the United States but due to recent shortages, many contractors were forced to use the Chinese made Drywall.

The company behind the supply of the defective products  is Knauf Plasterboard Tianjin Co. Ltd. of China, a subsidiary of German-based manufacturer Knauf Group.

The health department  said that most of the homes being investigated were built after 2004, but one home that is the subject of complaints was built in 2001.

The U.S. Consumer Product Safety Commission and Florida Department of Health have announced their own investigations to determine whether the Chinese drywall poses a threat to public safety or health.

The U.S. Consumer Product Safety Commission said last week it was investigating complaints that Chinese-made drywall was emitting odors and causing appliance problems in homes.

Several people have come forward and many more are expected to as Florida homeowners find out that issues are related to the Chinese Drywall.


BPA baby bottle Ban – NY Law Makers Vote

March 4, 2009 by Jay Genkins  
Filed under Defective Products

NY county lawmakers vote to ban GARDEN CITY, N.Y. (AP) — Lawmakers in a Long Island county have voted to approve what would be the nation’s first ban on baby bottles and toddler sippy cups made with a chemical that some studies suggest may be harmful to infants.

The ban on Bisphenol-A (BPA) was approved unanimously by the Suffolk County Legislature on Tuesday. It will take effect if County Executive Steve Levy signs it, but he has not indicated whether he will do so.

The FDA had said last fall that BPA was safe, but after an independent report found deep flaws in its study the agency announced in December that it was planning more research.


No Limit on Lawsuits against Drug Makers upheld by Supreme Court

courtIn a win for consumers, the United States Supreme Court has upheld a law that would have limited the amount of money in lawsuits against drug makers.

The Supreme Court has upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea that it limit lawsuits against drug makers.

In a 6-3 decision Wednesday, the court rejected Wyeth Pharmaceuticals’ claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont.

The decision is the second this term that rejected business groups’ arguments that federal regulation effectively pre-empts consumer complaints under state law.


Raptiva Psoriasis Drug Side Effects FDA Warning

Raptiva Psoriasis Drug Side Effects warning issued by the FDA.

raptivaThe U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died.

All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.

The FDA is reviewing this latest information. The agency will take appropriate steps to:

  • ensure that the risks of Raptiva do not outweigh its benefits;
  • that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
  • that health care professionals carefully monitor patients for the possible development of PML.

The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system.

These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient’s susceptibility to infections.

Since the approval of Raptiva (efalizumab) in October 2003, the FDA has received reports of three confirmed cases and one possible case of progressive multifocal leukoencephalopathy (PML) in patients who were 47 to 73 years of age who were using Raptiva for the treatment of moderate to severe plaque psoriasis.

Two of the patients with confirmed PML and one patient with possible PML died. All four patients were treated with Raptiva continuously for more than three years.  None of the patients were receiving other treatments that suppress the immune system while taking Raptiva.

PML is a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system.  When PML occurs, it is usually in people whose immune systems have been severely weakened and often results in an irreversible decline in neurologic function and death. There is no known effective treatment for PML.

Raptiva works by affecting T-cells in the immune system.  The effects of Raptiva also decrease the function of the immune system and increase susceptibility to infections.

Raptiva was approved for the treatment of moderate to severe plaque psoriasis in 2003. There were no cases of PML seen in the clinical trials that supported the approval of Raptiva.  At the time of approval, a total of 2,764 patients had been treated with Raptiva.  Of those 2,764 patients, 2400 had been treated for three months, 904 for six months, and 218 for one year or more.

In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML.  In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva.

The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML.

Healthcare providers should, in the interim, be aware of the following information and advice:

  • Raptiva increases the risk of PML.  Longer, continuous use may further increase this risk.
  • Inform patients using Raptiva of the potential risk of developing PML.
  • There are no known screening tests that can reliably predict PML or medical interventions that can prevent or treat this disease.
  • Monitor patients being treated with Raptiva for the onset of neurologic symptoms.  Discontinue Raptiva if PML is suspected.
  • Patients treated with Raptiva should be periodically re-evaluated to ensure that the benefit of treatment continues to outweigh the risks.  Consideration should be given to use of other approved therapies to control the patients’ psoriasis.
  • The effects of periodic or intermittent use of Raptiva, or the concomitant use of other immunosuppressant drugs on the risk for PML is not known.

Patients using Raptiva should:

  • Be aware that Raptiva increases the risk of developing PML.  PML is a disease that is fatal or causes severe disability.
  • Talk with their healthcare provider about the benefits and risks of treatment with Raptiva.
  • Be aware of the symptoms of PML which may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and sometimes personality changes.
  • Contact their healthcare provider immediately if they experience these symptoms.
  • Understand that there are no laboratory screening tests for PML or medical interventions that can prevent or treat PML

In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.

According to Reuters,  Genentech Inc (DNA.N) is developing plans to minimize the risks of a deadly infection reported in patients who took the company’s Raptiva psoriasis drug, a company spokeswoman said on Thursday.
The European Medicines Agency recommended suspension of Raptiva’s marketing approval after three confirmed reports of progressive multifocal leukoencephalopathy, or PML. U.S. regulators said they were reviewing the cases.

“We are evaluating all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan,” Genentech spokeswoman Tara Cooper said.

Genentech markets Raptiva in the United States. Merck Serono, a unit of Merck KGaA (MRCG.DE), holds marketing rights to Raptiva in Europe. (Reporting by Lisa Richwine, editing by Lisa Von Ahn)

Infections, including serious infections leading to hospitalizations or death, have been observed in patients treated with RAPTIVA . These infections have included bacterial sepsis, viral meningitis, invasive fungal disease and other opportunistic infections. Patients should be educated about the symptoms of infection and be closely monitored for signs and symptoms of infection during and after treatment with RAPTIVA. If a patient develops a serious infection, RAPTIVA should be discontinued and appropriate therapy instituted.

Progressive Multifocal Leukoencephalopathy PML) resulting from JC virus infection has occurred during therapy with RAPTIVA.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

The FDA asks health care providers and patients to report possible cases of PML to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html

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Complete List Peanut Butter Products Recalled to Date

February 11, 2009 by Jay Genkins  
Filed under Defective Products, FDA, Guides

peanut_butterPlease see below for the complete list of recalled peanut butter products as of Feb 10 2009.

For the current list and more information, the best place to go is the FDA page dedicated to this.
http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html

Peanut Butter Recall List – Feburary 2009 FDA Press Releases

Peanut Butter Recall List – January 2009 FDA Press Releases

Back to Top of Page


January 2009 Press Releases

—————-More information from the CDC———————-

Update for February 9, 2009 (next web update will be available Thursday, February 12)

Today’s Highlights

salmonella under microscope

Outbreak Investigation | Recommendations/Advice to Consumers | Clinical Features/Signs and Symptoms | CDC’s Role in Food Safety | Previous Updates

Why has Salmonella been in the news recently?

The Centers for Disease Control and Prevention (CDC) has been receiving reports, from many states, of illnesses caused by a type of Salmonella called Salmonella Typhimurium. Several deaths may also be associated with this outbreak. Tests indicate that the people who became sick may have eaten the same contaminated food, because they were infected with the same strain of Salmonella Typhimurium (i.e., the strain of Salmonella shared the same genetic “fingerprint”). Additional information on the numbers of illness and the states in which they occurred can be found at www.cdc.gov/salmonella/typhimurium/.

Is the salmonellosis outbreak definitely linked to peanut butter?

A combination of epidemiological analysis and laboratory testing by state officials in Minnesota and Connecticut, the Food and Drug Administration (FDA), and CDC enabled FDA to confirm that the sources of the outbreak were peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) at its Blakely, Georgia, processing plant. Peanut paste is a concentrated product consisting of ground, roasted peanuts that is distributed to food manufacturers to be used as an ingredient in many commercially produced products including cakes, cookies, crackers, candies, cereal and ice cream.


Lean Cuisine Chicken Recall – Nestle Recall

November 18, 2008 by Jay Genkins  
Filed under Defective Products

Thousands of Lean Cuisine Chicken Meals have been recalled by Nestle. The world’s biggest food company, has announced a recall of about 880 thousand pounds of Lean Cuisine Chicken Meals that may contain foreign materials, the U.S. Department of Agriculture said.

Nestle received one report of injury and identified the objects as small pieces of hard plastic, the USDA said in a statement today.


White Rabbit Candy Recall -Possible Health Risk – Melamine

September 29, 2008 by Jay Genkins  
Filed under Defective Products

September 26, 2008 -

No illnesses associated with this product have been reported to date however as a precaution QFCO, Inc. of Burlingame, California is recalling White Rabbit Candy because it may be contaminated with Melamine.

Product was distributed to the states of CA, GA, HI, IL, MN, NY, OR, TX, WA through wholesale distributors to retail stores.

The White Rabbit Creamy Candy is sold in 8 or 16 oz packages. All other flavors of White Rabbit Candy, including Assorted (Chocolate, Coconut, and Coffee), Red Bean, Coffee, Corn, Lychee, Mango and Strawberry are sold in 7 oz. packages. All packaging has a logo of a white rabbit on the front with the words “White Rabbit”.

The recall was initiated after it was discovered that product was contaminated with Melamine.

Consumers who have purchased White Rabbit Candy are urged to return it to the place of purchase for a full refund or discard it in their trash.

Consumers with questions may contact the company at (650) 697-6633.


Remicade, Enbrel, Humira and Cimzia- FDA Warning – Tumor Necrosis Factor Blockers & Cancer

June 5, 2008 by Jay Genkins  
Filed under Defective Products, FDA, HEALTH, Top Stories

fda-logo2The FDA released an advance Communication regarding an Ongoing Safety Review to inform health care professionals that the Agency is looking into a potential connection between the use of Tumor Necrosis Factor (TNF) blockers and the maturation of lymphoma and other cancers in children and young adults. FDA is investigating around 30 reports. The reports were presented to the FDA’s Adverse Event Reporting System during a ten-year period, starting in 1998 through April 29, 2008.

These reports identify cancer occurring in children and young adults who started taking TNF blockers (and other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), while they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn’s disease or other diseases. Around 1/2 of the cancers were lymphomas, including  Hodgkin’s and non-Hodgkin’s lymphoma.

Long-term studies are required to render conclusive replies about whether TNF blockers increase the happening of cancers in children since cancers could take a long time to arise and may not be observed in short-term studies. Until the evaluation is finished, healthcare providers, parents, and caregivers should be mindful of the conceivable risk of lymphoma and other cancers in children and young adults when choosing how to better treat these patients.


Contaminated Heparin Victims Families talk about deaths

April 30, 2008 by Jay Genkins  
Filed under Defective Products

WASHINGTON – The widow of a man who died after receiving contaminated heparin told a congressional subcommittee Tuesday “we have a false sense of security” in a land where people expect to be protected and safe.

Brushing away tears, Johanna Marie of Toledo, Ohio, said her husband, Dennis, was looking forward to his 60th birthday party on the last day of his life.

Contaminated heparin, a blood thinner used in dialysis and other treatments, has been connected to 81 deaths and 785 severe allergic reactions, said Rep. Bart Stupak, D-Mich., chairman of the House Energy and Commerce subcommittee on oversight and investigations.

The heparin, made from ingredients imported from China, has been recalled by Baxter International and the Food and Drug Administration has blocked imports from the Chinese company.

The FDA found the drug was contaminated with oversulfated chondroitin sulfate, which mimics heparin and thus was not detected in routine testing, Stupak noted.

Source

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Evenflo Car Seat Recall – One Million Discovery Seats Recalled

February 1, 2008 by Jay Genkins  
Filed under Defective Products, Recalls

About one million child safety seats made by Evenflo are being recalled because they could fail to protect children from vehicle side-impacts.The seats being recalled are Evenflo Discovery child safety seat models 390, 391, 534 and 552 made between April 2005 and January 29, 2008. The serial number and date of manufacture can be found on a white label on the underside of the safety seat.

Owners of the affected Discovery safety seats are urged to immediately contact Evenflo and receive a free dual-hook fastener that will secure the seat to its base. Parents should continue using the safety seats while waiting for their fasteners to arrive, said NHTSA.

NHTSA urges parents affected by the recall to contact Evenflo at 1-800-356-2229 between the hours of 8am and 5pm EST, or visit the Evenflo web site: http://safety.evenflo.com/cs/sc/cssc_RD.phtml.

Related Child Car Seat Recall Information


NuCel Eye Drop Recall and Eye Wash Products. Recall

January 31, 2008 by Jay Genkins  
Filed under Defective Products, Recalls

January 31, 2008

The FDA announced a recall to consumers and healthcare professionals about NuCel Labs voluntarily Eye Drop Recall and Eye Wash Products. This is a nationwide recall due to testing which indicated potential bacteria and particulate matter making the products non-sterile. Use of the products poses an unacceptable risk of eye infections and in rare cases blindness or loss of vision.

There are presently no reported injuries and consumers are asked to discontinue use and immediately return the product to NuCel Lab. If you or a loved has been injured from using these products please seek immediate medical attention. Our law firm is presently investigating injuries and eye infections from the use of this product.

Contact us today for a free confidential case review.


Fire Star – Dura Star Balloon Catheters Recall

The FDA along with Cordis Corporation have issued a Class I recall of All Fire Star and Dura Star balloon catheters.

The defective medical device lots recalled are13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart.

Cordis Recall

Products manufactured in Mexico from February, 2007 through December, 2007 and distributed worldwide from March 26, 2007 through January 8, 2008. Dura Star™ RX was distributed in the U.S. on August 29, 2007 and Fire Star™ RX was distributed in the U.S. on August 31, 2007.

The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.

Consumers with questions may contact Cordis, Inc. at 1-786-313-2000

For Legal Questions and assistance call 1-866-242-0905 or visit the Fire Star Recall section.


Thomas Toymakers to Pay 30 Million Dollars Settlement

January 23, 2008 by Jay Genkins  
Filed under Defective Products, Recalls

The maker of “Thomas & Friends Wooden Railway” toys has agreed to pay $30 million to settle a nationwide class-action lawsuit by thousands of families who purchased lead-tainted products, a plaintiffs’ attorney said Wednesday.Under the deal, Oak Brook-based RC2 Brands will offer cash refunds or replacement toys, plus what the company calls a bonus toy; it also promises to implement new quality controls, said Jay Edelson, a plaintiffs’ attorney in the case.

“We believe this really is the first step toward cleaning up the problem of lead paint in toys,” the Chicago attorney said. “It will put a lot of pressure on other companies to step up and act morally. We hope this becomes a problem of the past.”

The lawsuit was filed in the Circuit Court of Cook County last year, and the court gave the settlement preliminary approval on Tuesday. The judge is expected to give final approval at a hearing set for May 6, Edelson said.

This is the latest string in Toy Recalls and Defective Products recently in the US and Abroad.

Here is a short list from the recall and Consumers can also contact RC2 at (866) 725-4407 between 8 a.m. and 5 p.m. CT Monday through Friday or visit the firm’s Website at http://recalls.rc2.com

The front of the packaging has the logo “Thomas & Friends Wooden Railway” in the upper left-hand corner.

A tracking code may be located on the bottom of some of the products. Toys marked with codes containing “WJ” and “AZ” are not included in the recall.

The All-Black Cargo Car, included only in the Brendam Fishing Dock Set, is labeled “CARGO CAR” and has either no tracking code or one of the following codes on its undersides: 26833i, 28233i, 23243i00, 24643i00, 25343i00, 27443i00, 32043i00, 34743i00, 01553i00, 04553i00, 13353i00, 14753i00, 15453i00, 18353i00.

The toad vehicle with brake lever is labeled “TOAD” and has the tracking code 16560W000 on its underside. The Olive Green Sodor Cargo Box says “SODOR” on the side. The box was included only in the Deluxe Cranky the Crane Set.

The All-Green Maple Tree Top and Green Signal Base accessories were included only in Conductor’s Figure 8 Sets.

Cargo cars sold in other sets are not included in the recall.

If you believe that you have been adversely affected by a toy recall you can visit www.resource4thepeople.com for more information and legal help.


FDA Warns Stryker Howmedica Osteonics on Hip Implant

January 21, 2008 by Jay Genkins  
Filed under Defective Products, FDA, Features

January 16, 2008

Stryker Howmedica Osteonics manufactures femoral hip components that are used for surgical implants.

The FDA has warned Stryker to fix the hip implant problems: In a letter to Stryker Federal Regulators wrote:

“Your firm has not identified the root causes of the microorganism contamination and has not executed corrective and preventive action to prevent recurrence,” the letter states.

The FDA said it was aware that the company has received patient complaints starting January 2005 on many existing problems. Reported problems include improper fitting of hip implants that has caused bone fractures. Patients were also known to have complained about pain, difficulty walking and “squeaky” joins, and some have even had pieces of the implant parts break off.

If you have been hurt, injured or have experienced any problems with a Stryker Hip Implant, contact us today for a free case evaluation. www.resource4thepeople.com

1-866-242-0905


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