Z-0668-2008

Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection...

Name: Z-0668-2008 Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2007-12-18
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2007-12-18 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur... on 2007-12-18. The reason FDA records is "The GMRS Proximal Femoral Surgical Protocol states " The GMRS Proximal Femoral components are fully compatabile with all Stryker V40 femoral heads." This statement is incorrect and conflicts with the Alumina Head label...". 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-0668-2008
Status: Terminated
Initiated: 2007-12-18
Posted: 2008-04-22
Terminated: 2008-10-15
Recalling firm: Howmedica Osteonics Corp
Product: Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur Prosthesis Surgical Literature, Stryker Orthopaedics, Mahwah, NJ 07430
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: The GMRS Proximal Femoral Surgical Protocol states " The GMRS Proximal Femoral components are fully compatabile with all Stryker V40 femoral heads." This statement is incorrect and conflicts with the Alumina Head label and packaging insert.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Stryker sent Urgent Product Recall notification letters and Product Accountability forms via FedEx on 12/21/2007, return receipt requested. An Urgent Product Recall letter dated 1/7/2008, was sent to surgeons who are GMRS users, advising that the GMRS Proximal femoral components are not compatible with Alumina ceramic heads.
Quantity in commerce: 5869
Distribution: Worldwide Distribution - USA, Canada, Mexico, China, Australia, Hong Kong, Singapore, Sweden, Germany, Brussels, the Netherlands, Italy, Poland, Dubai, United Kingdom, Spain, and South Africa.
Product codes and lots: Literature number: LSPK41; 10 surgical protocols per package.

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)