FDA Enforcement
Class II
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.
Recall: Z-2438-2015
·
Reported September 2, 2015
Enforcement
- Recall Number
- Z-2438-2015
- Event ID
- 71950
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Otto Bock Healthcare Product
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- September 2, 2015
- Initiation Date
- August 12, 2015
- Classification Date
- August 21, 2015
- Termination Date
- October 28, 2015
- Address
- Brehmstrasse 16, N/A, Wien, N/A, N/A, Austria
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
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.
Code Info
Serial Number 201528049, manufactured on 01 July 2015
Distribution
Distributed to the state OH.
Quantity
1