Zimmer Biomet, Inc. recalls ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item…
- Recall date
- September 24, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0340-2021
- FDA classification
- Class II
- Brand / firm
- Zimmer Biomet, Inc.
- Sold / distributed
- US Nationwide
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-32
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