FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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
- Recall number
- Z-0668-2008
- Recalling firm
- Stryker 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
- Status
- Terminated
- Initiated
- 2007-12-18
- Posted
- 2008-04-22
- Terminated
- 2008-10-15
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Literature number: LSPK41; 10 surgical protocols per package.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28