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U.S. Department of Health and Human Services

Class 2 Device Recall Gamma3 Set Screwdriver

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 Class 2 Device Recall Gamma3 Set Screwdriversee related information
Date Initiated by FirmFebruary 22, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on October 25, 2010
Recall NumberZ-1627-2008
Recall Event ID 46963
Product Classification Screwdriver - Product Code HXX
ProductGammas Set Screwdriver Instrument Set, Basic Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 - Orthopedic Device. The Gamma3 Locking Nail Systems are intramedullary short and long fixation nails intended for control of rotation and shortening of fractured femurs. The screwdriver is used to place the set screw in the nail.
Code Information Product number: 1320-6000; Lot code engraved on screwdrivers: K887079 and K782153.
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactRita Intorella
201-831-5825
Manufacturer Reason
for Recall		Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification.
FDA Determined
Cause 2		Finished device change control
ActionOn February 22, 2008 Urgent Product Recall notification letters were sent to Stryker Branches/Agencies, Risk Management Departments at hospitals and surgeons via Federal Express. If you have any questions contact Rita Intorrella at (201) 831-5825 or the Hip Fracture Team at (201) 831-5291.
Quantity in Commerce43 total (single and kits)
DistributionClass II Recall - Nationwide Distribution.
Total Product Life CycleTPLC 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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