Residue left on some Zimmer M/L Taper hip implants during the manufacturing process could pose serious risks for patients, according to a recall notice posted this month by federal safety regulators.Â
The FDA has announced that it is classifying a Zimmer M/L Taper Femoral Stem and Neck recall as a class I medical device recall, suggesting that the risks associated with the device may cause severe adverse health consequences or even death.
According to the notice posted on June 8, Zimmer discovered that a process monitoring failure led to higher than expected levels of a certain manufacturing residue left on the hip implants. The FDA does not identify the residue, but warns that it can cause serious adverse health problems, including allergic reactions, infections, pain, and potentially death. There have been no incidents linked to the recalled femoral stems and necks.
At least 62 lot of femoral stems and necks used during Zimmer hip replacements are impacted by the recall, and the FDA indicates that patients who have already had these devices implanted may need to undergo revision surgery to have the implant replaced. A complete list of the lot numbers of the affected devices can be found in the recall notice.
The implants were manufactured and distributed by Zimmer, Inc. from March 31, 2015 through April 20, 2015. The company issued notification letters to distributors and hospital staff on May 18.
The company asked distributors to identify affected products in their inventory, quarantine them, and return the recalled implants for a full refund. The company also asked distributors to notify any hospitals or surgeons they believe purchased the recalled implants.
Any patients with questions or concerns can contact Zimmer customer service at 1-877-946-2761. Health care professionals and consumers who have experienced adverse reactions linked to the recalled femoral stems and necks should submit a report to MedWatch, the FDA’s adverse event reporting system.