Product Wiki · Recalls · U.S. FDA — Device Enforcement

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-22 — recall Z-0371-2021

U.S. FDA — Device Enforcement · United States · 2020-09-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0371-2021
Date of alert
2020-09-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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