New Hip Implant Recall-Zimmer M/L Taper with Kinectiv Technology System
Posted by Richard R. Schlueter
June 23, 2015 1:36 PM
The American Academy of Orthopaedic Surgeons has just issued a Patient Safety Member Alert on the Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks. This is a Class 1 Recall per the FDA.
Per the AAOS and the FDA website, The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Zimmer M/L Tapers with Kinectiv Technology Femoral Stems and Necks. The company found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant. At this time, the company has not received any complaints related to this issue for any of the lots in distribution.
On May 18, 2015, Zimmer issued recall notification letters with the following instructions for hospital staff, including risk managers and surgeons:
Review the notification and ensure affected personnel are aware of the contents.
Assist your Zimmer sales representative with the quarantine of any affected product.
Your Zimmer sales representative will remove the recalled product from your facility.
The Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks are implants used for hip replacements.
Read more here: Legal Examiner