Z-1043-2016Class II

Columbus Revision Knee System, EnduRo Knee System

Name: Z-1043-2016 Columbus Revision Knee System, EnduRo Knee System
Creator: Aesculap, Inc.
Published: 2015-11-30
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2015-11-30 / Terminated / root cause: packaging

FDA source

Aesculap, Inc. began a recall of Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in... on 2015-11-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1043-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-30
Posted: 2016-03-03
Terminated: 2016-10-13
Recalling firm: Aesculap Inc
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Aesculap sent an Urgent Medical Device Correction letter to Distributors and Sales Rep. The letter identified the affected product, problem and actions to be taken. Customers were notified to add the over label to product packaging. Telephone conferences with Distributors and Sales Rep reiterated need for representative to inform Surgical Handler of the label when providing product for review. Customers were instructed to complete the attached Product Correction Acknowledgement Form and return to Aesculap Quality Assurance department by faxing the form to 610-791-6882 or e-mail to [email protected], two (2) weeks of receipt, even if the total inventory in your possession is zero (0).
Quantity in commerce: 1232
Distribution: US Nationwide Distribution
Product codes and lots: All codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1043-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1043-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03

Product code JWH

K083772Class IIColumbus Revision Knee SystemAesculap Implant System, Inc. / cleared 2009-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)