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Recall Observatory FDA recall evidence

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

November 30, 2015

Class II

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

    reason.no_named_rule · v1.0.0

    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.