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

Recall Z-2130-2021 — Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.

U.S. FDA — Device Enforcement · United States · 2021-06-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2130-2021
Date of alert
2021-06-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10885862024503
Reported risk: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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