Potentially elevated endotoxin levels led Zimmer Biomet to issue a recall in Europe of certain polyethylene orthopedic implants for knees, hips and extremities.
Three quick notes:
1. The April 30 recall applies to polyethylene implants manufactured between December 2016 and January 2017, and distributed between December 2016 and February 2020.
2. During a routine bacterial endotoxin testing of polyethylene implants, three samples were found to exceed accepted standards for endotoxin levels during a six-week period.
3. Zimmer Biomet did not receive any complaints related to the issue, which could cause adverse local tissue reactions, critical pain or aches, and severe, systemic reactions.