Z-1793-2012Class II

Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision...

Name: Z-1793-2012 Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision...
Creator: Aesculap Implant Systems
Published: 2012-02-21
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2012-02-21 / Terminated / root cause: manufacturing process

FDA source

Aesculap Implant Systems began a recall of Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in... on 2012-02-21. FDA classified it as Class II and gives the reason as "During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1793-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-21
Posted: 2015-06-26
Terminated: 2014-01-15
Recalling firm: Aesculap Inc
Product: Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: During an internal quality inspection, the tibia plateau was found to be out of specification. There is a potential for misalignment between the tibia plateau and attachment of the extension stem.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Aesculap Implant Systems (AIS) initiated their recall of this product by first telephoning consignees and then on February 21, 2012 by sending an IMPORTANT RECALL NOTIFICATION letter dated February 21, 2012 to all consignees. The letter identified the affected product, problem and actions to be taken. The notification told consignees not to use the affected product and to return any stock to AIS (USA) promptly. For questions contact Scott Stephan at (610) 984-9239 or Christian Gabriel at (610) 984-9300.
Quantity in commerce: 8
Distribution: Nationwide Distribution including PA and TX.
Product codes and lots: NR068K, TIBIA PLATEAU, FIXED, T0; NR070K, TIBIA PLATEAU, FIXED, T0+; NR072K, TIBIA PLATEAU, FIXED, T1; NR072K, TIBIA PLATEAU, FIXED, T1+; NR073K, TIBIA PLATEAU, FIXED, T2; NR074K, TIBIA PLATEAU, FIXED, T2+; NR075K, TIBIA PLATEAU, FIXED, T3; NR076K, TIBIA PLATEAU, FIXED, T3+; NR077K, TIBIA PLATEAU, FIXED, T4; NR078K, TIBIA PLATEAU, FIXED, T4+; NR079K, TIBIA PLATEAU, FIXED, T5

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1793-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1793-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-20	2012-06-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)