Earlier this month, Zimmer initiated a voluntary recall of certain M/L Taper with Kinectiv Technology Femoral Stems and Necks used in hip replacements.
The recall, which Zimmer is calling a “process monitoring failure,” is due to higher than expected amounts of manufacturing residues left on the devices. The FDA is categorizing this as Class 1, the most serious type of recall. These residues can cause serious adverse health issues including:
Use of the recalled products may require the need for a revision surgery to replace the affected implant.
According to the FDA’s website, Zimmer, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated May 18, 2015, to all affected consignees. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification and ensure affected personnel are aware of the contents.
If you or a loved one have had a Zimmer® M/L Taper with Kinectiv® Technology Femoral Stem hip replacement in 2015, call the law firm of Meshbesher & Spence at 1-888-728-9866 or fill out the short case evaluation form on this page.