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

Recall Z-2438-2015 — Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.

U.S. FDA — Device Enforcement · Austria · 2015-08-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2438-2015
Date of alert
2015-08-12
Country / jurisdiction
Austria
Risk level
Class II
Risk type
recall
Brand
Otto Bock Healthcare Product
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
201528049
Reported risk: Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.
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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