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

Recall Z-1296-2024 — SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

U.S. FDA — Device Enforcement · Germany · 2024-02-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1296-2024
Date of alert
2024-02-06
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Waldemar Link GmbH & Co. KG (Mfg Site)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04026575387168
Reported risk: Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during 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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