FDAFDA · Food and drugs·Recall number Z-1043-2016
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.
Published March 9, 2016 · Recall initiated: November 30, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- US Nationwide Distribution
- Lot
- All codes
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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