Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile 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.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- February 22, 2008
- Posted
- September 16, 2008
- Terminated
- October 25, 2010
- Recall Number
- Z-1626-2008
- Quantity
- 43 total (single and kits)
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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. If the screwdriver tip were to deform intra-operatively, the correct positioning of the set screw would not be possible, which could lead to lateral or medial migration of the lag-screw.
Distribution
Class II Recall - Nationwide Distribution.
Lot / Code Info
Product number: 1320-0231 Lot Code on Package label K409181, Lot code engraved on Screwdriver: K968226; Lot code on package label: K610297, Lot code engraved on Screwdriver: K782153; Lot code on package label; K645667, Lot code engraved on screwdriver: K533686; Lot code on package label: K688034, Lot code engraved on screwdriver: K887079; and Lot code on package label: K878962, Lot code engraved on screwdriver: K533686.
Root Cause
Finished device change control
Action Taken
On 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.