Stryker Accolade Recall 2009
In the wake of the new potential recall of the Stryker Accollade Hip, it is important to understand that the Accolade TMZF Hip Stem recall of 2009, 2011, and 2013 were primarily due to packaging and manufacturing errors.
Unfortunately corrosion and fretting has been discovered in implanted devices requiring a massive recall
If you or a loved one has a recalled hip, call The DiCello Law Firm at (888)778-8880 so we can help you get justice.
Why did these Stryker Hip Implants get to market?
The Stryker Corporation took advantage of an FDA process called the 501(k) approval. This allowed them to bring the Rejuvenate and ABG-II modular hip implant to market with minimal testing. Under the 510(k) program, a drug or medical device can be offered to the public without having to undergo clinical trials. Of course Stryker had to show that the product is substantially similar to a product that has already received FDA approval.
For its Rejuventate and ABG II systems Stryker was required to only conduct post market surveillance instead of testing the devices before they entered the market.
What was the problem with the 2011 Stryker Accolade Recall?
According to the FDA recall notice "Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole."
Accolade II 501(k) Status
The Stryker corporation has gone through the 501(k) line extension approval process for its Accolade II hip system and this device has been used in patients over the last months. We are following the developments of any potential recalls or claims of significant health problems with this hip replacement device.
What Does This Mean For You, The Patient?
Please be proactive with your health issues. If past occurrences have taught us anything it is "Don't wait for the FDA or the hip manufacturers to issue a recall notice!" If you have any problem with your implant call for legal advice, as neither FDA or (obviously) the device manufacturer are looking out for your best interest. This is especially true when it comes to the financial burden that is associated with secondary hip replacement procedures.
Why The DiCello Law Firm?
The DiCello Law Firm lawyers are among the leading lawyers in this area. They have already filed Stryker Rejuvenate and ABG-II modular hip implant cases. We know that the market is filled with advertisements of lawyers that will get you the 'best financial retribution possible' but our promise to you is that we treat every client as we would our own family.
If you or a loved one believes that they have been injured by a hip replacement product call the lawyers at The DiCello Law Firm at (888)778-8880, for an immediate and frank discussion about how we can help you.