24 Jun Class 1 Recall Issued for Zimmer Femoral Hip Implants
Certain Zimmer hip implants are now being recalled in the U.S. due to findings that residues left on these implants may put patients at risk of developing potentially life-threatening complications.
This recall announcement, which was issued by regulators at the U.S. Food and Drug Administration (FDA) on June 19th, specifically impacts the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks with manufacturing and distribution dates from March 31, 2015 through April 20, 2015.
Below, we’ll point out what else you may need to know about this urgent recall.
Zimmer Hip Implant Recall – The Following Is Important to Know
- This is a Class I recall – In other words, this is the most serious type of recall that can be issued by the FDA, and it indicates that the device in question has the potential to “cause serious adverse health consequences or death.”
- The potential complications can be fatal – In fact, the excess manufacturing residues that have been left on the recalled Zimmer hip implants can reportedly cause people to develop severe allergic reactions, as well as serious infections and/or severe pain. In the worst cases, these complications have the potential to be fatal.
- Zimmer discovered the problem – According to the FDA, Zimmer “found a process monitoring failure” that resulted in the manufacturing residues being present in excessive amounts on the recalled hip implants.
- There haven’t been any reports to date about patient complications – Zimmer has revealed that, to date, it has not received any reports that patients with these implants have developed adverse health complications. However, this doesn’t mean that complications haven’t occurred, as it may take time for the public to become aware of this recall and, consequently, know how and where to report complications they have experienced.
As more news about this recall becomes available, we’ll bring you the latest updates in a future blog. Until then, please post your comments and thoughts about this recall on our Facebook & Google+ pages.
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