FDA-Device2016-03-09Class II
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.
Aesculap, Inc.
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
1232
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1043-2016Don't want to check this manually?
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