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U.S. Department of Health and Human Services

Class 2 Device Recall GMRS Proximal Femoral Surgical Protocol

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  Class 2 Device Recall GMRS Proximal Femoral Surgical Protocol see related information
Date Initiated by Firm December 18, 2007
Date Posted April 22, 2008
Recall Status1 Terminated 3 on October 15, 2008
Recall Number Z-0668-2008
Recall Event ID 46275
Product Classification Femur Prosthesis Surgical Literature - Product Code JDI
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
Code Information Literature number: LSPK41; 10 surgical protocols per package.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Larry Ross
201-831-5972
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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