Stryker Howmedica Osteonics Corp. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Stryker Howmedica Osteonics Corp. is recalling Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma Gmb due to Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification. If the screwd. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026