Z-1241-2007

Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325

Name: Z-1241-2007 Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-10-17
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-10-17 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325 on 2006-10-17. The reason FDA records is "Loose fixation pegs: One lot of femoral components may have loose fixation pegs". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1241-2007
Status: Terminated
Initiated: 2006-10-17
Posted: 2007-09-21
Terminated: 2009-07-07
Recalling firm: Howmedica Osteonics Corp
Product: Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Loose fixation pegs: One lot of femoral components may have loose fixation pegs.
FDA root cause: Other
Action: Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product.
Quantity in commerce: 3 total, 2 in USA
Distribution: Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden.
Product codes and lots: Product No. 6632-0-325; Lot code UCVO

Product code JWH

K920034Class IIDuracon Modular Femoral Component and Femoral SpacPfizer Hospital Products Group, Inc. / cleared 1992-03-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)