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

Recall Z-0097-2021 — (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 M

U.S. FDA — Device Enforcement · United States · 2020-09-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0097-2021
Date of alert: 2020-09-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 110010458

Reported risk: Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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