Recall Z-1043-2016— Aesculap, Inc.

Name: FDA recall Z-1043-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-30

Class II · Terminated

Class II FDA medical device recall by Aesculap, Inc., initiated 2015-11-30, terminated 2016-10-13. It names one FDA 510(k) clearance: K083772. 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.. 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..

Recalling firm: Aesculap, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-30
Terminated: 2016-10-13
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K083772 — COLUMBUS REVISION KNEE SYSTEMAesculap Implant System, Inc.·cleared 2009-06-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.