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Terminated

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.

FDA Recall Z-2438-2015 · Posted 2015-08-21

Recalling FirmOtto Bock Healthcare Product
Recall StatusTerminated
Product CodeISW
Date Initiated2015-08-12
Date Terminated2015-10-28
Product Quantity1

Reason for Recall

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.

Firm Action

The consignee was notified via e-mail and telephone on 12 August 2015. The affected product was identified, as well as the reason for the recall. The firm will replace the affected device with a new one. A return authorization and label will be provided for the recalled product to be returned as soon as possible.

Root Cause

Process control

Distribution Pattern

Distributed to the state OH.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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