Z-2438-2015 Class II Terminated
FDA device recall Z-2438-2015 was initiated by Otto Bock Healthcare Product on August 12, 2015 and is designated Class II. 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. The recall status is terminated (terminated October 28, 2015). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2015
- Initiation Date
- August 12, 2015
- Termination Date
- October 28, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
Distributed to the state OH.
Code Information
Serial Number 201528049, manufactured on 01 July 2015