Z-0241-06

Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail

Name: Z-0241-06 Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail
Creator: Stryker Howmedica Osteonics Corp.
Published: 2004-11-22
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2004-11-22 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail on 2004-11-22. The reason FDA records is "The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0241-06
Status: Terminated
Initiated: 2004-11-22
Posted: 2005-12-01
Terminated: 2006-10-03
Recalling firm: Howmedica Osteonics Corp
Product: Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
Product code: NDH Nail, Fixation, Bone, Metallic
Reason for recall: The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.
Quantity in commerce: 19
Distribution: The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.
Product codes and lots: Catalog 3220-0320S Lot K949408 3225-0360S, lot code K949396

Product code NDH

K034002Class IIGamma3 Nail SystemHowmedica Osteonics Corp. / cleared 2004-01-15

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)