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.
Reported: March 9, 2016 Initiated: November 30, 2015 #Z-1043-2016
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- Aesculap, Inc.
- Units Affected
- 1232
- Distribution
- US Nationwide Distribution
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Aesculap, Inc.. Units affected: 1232.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2016. Severity: Moderate. Recall number: Z-1043-2016.
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