Z-0014-2011

Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland...

Name: Z-0014-2011 Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2006-10-05
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2006-10-05 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland; Howmedica Osteonics; 325 Corporate Drive, Mahwah, NJ... on 2006-10-05. The reason FDA records is "Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0014-2011
Status: Terminated
Initiated: 2006-10-05
Posted: 2010-10-06
Terminated: 2010-10-07
Recalling firm: Howmedica Osteonics Corp
Product: Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland; Howmedica Osteonics; 325 Corporate Drive, Mahwah, NJ 07430 Intended for primary or secondary reconstruction of the distal femur.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Important Market Withdrawal Letters were sent via Federal Express October 5, 2006. The letters identified the affected product and the reason for recall. Customers were asked to examine their inventory to identify the product; and retrieve all affected product lots and return it their branch or agency warehouse for reconciliation. All product should be reconciled on the Product Accountability Form and the form should be faxed back. Customers are to contact a Customer Service Rep to re-order the product that is being returned. Questions can be directed to Rita Intorrella on 201-831-5825.
Quantity in commerce: 7 units
Distribution: Nationwide Distribution -- Including Ohio.
Product codes and lots: Lot Code: LADLF

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)