Reported Mar 9, 2016 · Terminated
Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee…
Aesculap, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesculap, Inc. · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- Columbus Revision Knee System
- EnduRo Knee System Product UsageThe Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint
- Lot codes and dates
- All codes
- Amount recalled
- 1232
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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