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U.S. Department of Health and Human Services

Class 2 Device Recall Gamma3 Plus

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  Class 2 Device Recall Gamma3 Plus see related information
Date Initiated by Firm March 02, 2009
Date Posted June 01, 2009
Recall Status1 Terminated 3 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/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
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 2
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.