Z-0391-2010

Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis...

Name: Z-0391-2010 Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-09-04
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-09-04 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component on 2009-09-04. The reason FDA records is "Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head". 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-0391-2010
Status: Terminated
Initiated: 2009-09-04
Posted: 2009-11-23
Terminated: 2013-06-26
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.
Product code: JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Reason for recall: Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.
Quantity in commerce: 10 units
Distribution: Nationwide distribution.
Product codes and lots: Catalog number 6260-9-132; Lot Code 28759003

Product code JDG

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)