Z-0492-2014Class II

Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7

Name: Z-0492-2014 Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
Creator: Aesculap, Inc.
Published: 2013-09-19
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2013-09-19 / Terminated

FDA source

Aesculap, Inc. began a recall of Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7 on 2013-09-19. FDA classified it as Class II and gives the reason as "The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0492-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-19
Posted: 2013-12-13
Terminated: 2014-12-22
Recalling firm: Aesculap Inc
Product: Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The Columbus Revision CoCr 15 mm distal and posterior implant spacers, sizes F5-F7, were not compatible.
FDA root cause: Component change control
Action: Domestic consignees were contacted by phone and a recall notification letters was also sent to these Users on/about September 26, 2013.
Quantity in commerce: 24
Distribution: Distributed in FL and MD.
Product codes and lots: lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0492-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0492-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13

Product code JWH

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)