Zimmer Biomet sent an urgent recall letter to hospitals and surgeons concerning its legacy Biomet products Sept. 25.
Six things to know:
1. The company said it is conducting voluntary field safety corrective action following concerns about an unnamed supplier that performs cleaning operations on Zimmer's products.
2. The letter states that the supplier received an FDA warning letter earlier this year after the products were "subject to cleaning processes that could result in elevated levels of bacterial endotoxin and residual debris remaining on the devices."
3. The supplier has been involved in the cleaning process of Zimmer products since March 2018.
4. The recall listed several products from Zimmer's extremities, hip, knee and trauma lines.
5. Zimmer named various health consequences that may result from use of exposure to the product tissue including adverse local tissue reaction, pain or ache, reaction to allergen or toxin and revision surgery.
6. Last month, Zimmer entered into a global license agreement with Bactiguard, an infection prevention technology company, to apply the technology to its orthopedic trauma implants.
The company provided the following comment when contacted by Becker's Oct. 2:
"Zimmer Biomet is dedicated to patient safety, and quality excellence is an integral aspect of our commitment to the patients and surgeons who rely on our products every day. We stand behind our products and will continue to take voluntary action to ensure their quality, safety and efficacy."