Aesculap, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1043-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 30, 2015

Date Posted: March 9, 2016

Recall Number: Z-1043-2016

Event ID: 72853

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.

Status: Terminated

Product Quantity: 1232

Code Information:

All codes

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated