Zimmer Biomet Recalls Polyethylene and Ceramic Implants in US and Canada
Following closely its recall of its reverse total shoulder implants, Zimmer Biomet recalls plastic and ceramic implant parts that are contaminated with endotoxins. Health Canada classifies the recalled products as posing a Type I Hazard.
The FDA has adopted approved standards for the presence of acceptable levels of endotoxins in orthopedic devices. This recall was announced after Zimmer Biomet found excessive levels of endotoxins in a sampling of devices. Endotoxins are toxins associated with the outer membrane of bacteria. In large enough quantities, endotoxins can cause hemorrhagic shock and severe diarrhea. Smaller amounts can cause fever and altered resistance to bacterial infection as well as other biologic effects. The release of endotoxins from bacteria can also impact other important physiologic processes as seen below.
As a result of the recall, Zimmer Biomet has communicated with surgeons and hospitals known to have implanted the recalled devices. The communication however does not give surgeons any specific advice as to what to do for the patient and no recommendation for treatment other than to follow the patient’s normal routine follow up schedule.
Only time will tell how many patients are adversely affected and what the consequences of these contaminated, recalled products will be.