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

Recall Z-0126-2023 — EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.

U.S. FDA — Device Enforcement · United States · 2022-08-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0126-2023
Date of alert
2022-08-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Encore Medical, LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00888912167055
Reported risk: Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
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.

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