Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection for Large
FDA device recall Z-0668-2008 · posted 2008-04-22 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 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.
- Date initiated
- 2007-12-18
- Date posted
- 2008-04-22
- Date terminated
- 2008-10-15
- Location
- Mahwah, NJ
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