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

Recall Z-0959-2017 — Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

U.S. FDA — Device Enforcement · Germany · 2016-10-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0959-2017
Date of alert
2016-10-27
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Brainlab AG
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04056481002626
Reported risk: Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing
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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