Z-0963-2008

Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy...

Name: Z-0963-2008 Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-11-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-11-02 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-528; Howmedica Osteonics Corp... on 2007-11-02. The reason FDA records is "Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0963-2008
Status: Terminated
Initiated: 2007-11-02
Posted: 2008-02-07
Terminated: 2010-08-30
Recalling firm: Howmedica Osteonics Corp
Product: Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-528; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland. Made in Ireland.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.
FDA root cause: Other
Action: Stryker Orthopaedics sent an Urgent Product Recall notification letters on November 9, 2007, by Federal Express with return receipt. The letter informed users of potential increased risk of stem neck fracture, when a V40 + 16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese. The firm has asked that inventory be examined, removed and held in quarantine. A Stryker representative will contact the medical facilities to retrieve the product. If a representative has not contacted the facility to date, it is suggested that they contact Stryker at (201) 831-5972.
Quantity in commerce: 5,599 total units
Distribution: Nationwide Distribution
Product codes and lots: V40 COCR HEAD 28mm/+16 -- Product Number: 6260-5-528 All lot codes

Product code JDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)