—#67097

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

FDA product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Literature number: LSPK41; 10 surgical protocols per package.

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

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.

Timeline

Recall initiated: 2007-12-18
Posted by FDA: 2008-04-22
Terminated: 2008-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67097. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.