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

Recall Z-1233-2026 — EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

U.S. FDA — Device Enforcement · United States · 2026-01-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1233-2026
Date of alert
2026-01-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Encore Medical, LP
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00888912167529
Reported risk: 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision 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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