Recall Z-2438-2015— Otto Bock Healthcare Product
Class II · Terminated
Class II FDA medical device recall by Otto Bock Healthcare Product, initiated 2015-08-12, terminated 2015-10-28. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Otto Bock Healthcare Product
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-12
- Terminated
- 2015-10-28
- Firm location
- Wien, N/A, Austria
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.