Z-1626-2008

Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma GmbH...

Name: Z-1626-2008 Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma GmbH...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2008-02-22
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2008-02-22 / Terminated

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, This product is non-sterile Stryker Trauma GmbH, Germany; Distributed by Howmedica Osteonics Corp., 325... on 2008-02-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1626-2008
Status: Terminated
Initiated: 2008-02-22
Posted: 2008-09-16
Terminated: 2010-10-25
Recalling firm: Howmedica Osteonics Corp
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.
Product code: HXX Screwdriver
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.
FDA root cause: Finished device change control
Action: 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.
Quantity in commerce: 43 total (single and kits)
Distribution: Class II Recall - Nationwide Distribution.
Product codes and lots: 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.

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)