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.
FDA Recall Z-1043-2016 · Posted None
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Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2015-11-30
Date Terminated2016-10-13
Product Quantity1232
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.
Firm 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).
Root Cause
Packaging change control
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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