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Zimmer Biomet, Inc. recalls ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Space
Recalled November 11, 2020 · FDA recall Z-0378-2021 · Zimmer Biomet
Hazard
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. · FDA Class II
Units
412 units total
Sold at
US Nationwide
Description
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.
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-32
Manufacturer(s)
Zimmer Biomet, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →