Device product
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
Z-1043-2016
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 72853
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1232
- Official record key
device-enforcement:Z-1043-2016
Official wording
Reason: Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.
Code information: All codes
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.