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
FDA Recall Z-0668-2008 · Posted 2008-04-22
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDI
Date Initiated2007-12-18
Date Terminated2008-10-15
Product Quantity5869
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.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
Worldwide Distribution - USA, Canada, Mexico, China, Australia, Hong Kong, Singapore, Sweden, Germany, Brussels, the Netherlands, Italy, Poland, Dubai, United Kingdom, Spain, and South Africa.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.