Zimmer Biomet, Inc. recalls ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethyle
Recalled Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 59 mm Number: 00-8065-656-28
Hazard / Issue
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.
Issued by
FDA
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