Z-1351-2009

Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System...

Name: Z-1351-2009 Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2009-03-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-03-02 / Terminated / root cause: labeling and UDI

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails on 2009-03-02. The reason FDA records is "Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1351-2009
Status: Terminated
Initiated: 2009-03-02
Posted: 2009-06-01
Terminated: 2012-08-17
Recalling firm: Howmedica Osteonics Corp
Product: Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.
Product code: JDS Nail, Fixation, Bone
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.
Root cause tag: labeling and UDI
FDA root cause: 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: 18232
Distribution: Nationwide.
Product codes and lots: Catalog number LG3-OT, no lot numbers, this is the surgical technique brochure.

Product code JDS

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)