Class 2 Device Recall Gamma3 Plus

• Date Initiated by Firm: March 02, 2009
• Date Posted: June 01, 2009
• Recall Status: Terminated on August 17, 2012
• Recall Number: Z-1349-2009
• Recall Event ID: 51409
• Product Classification: Operative Technique for Hip Fracture System - Product Code JDS
• Product: Stryker, Gamma3 Plus Obese Targeting System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.
• Code Information: Catalog number LG3P-OT, no lot numbers, this is the surgical technique brochure.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430
• For Additional Information Contact: Colleen O'Meara; 201-831-5000
• Manufacturer Reason for Recall: Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails.
• FDA Determined Cause: Labeling design
• Action: Stryker sent Urgent Product Recall letters by Federal Express on March 2, 2009 to Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. Letters were sent to all who have used the Gamma3 products in the past.
• Quantity in Commerce: 565
• Distribution: Nationwide.
• 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.