Zimmer Biomet, Inc.: Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.

Agency: Food and Drug Administration (FDA)

Event ID: 86521

Status: Resolved

Manufacturer: Zimmer Biomet, Inc.

Manufactured In: United States

Units Affected: 71 products (412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 unit total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units Total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 unit total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units Total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total; 412 units total)