Z-0256-06

Long Length Dyax Nail

Name: Z-0256-06 Long Length Dyax Nail
Creator: Stryker Howmedica Osteonics Corp.
Published: 2004-09-07
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2004-09-07 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Long Length Dyax Nail on 2004-09-07. The reason FDA records is "Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 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-0256-06
Status: Terminated
Initiated: 2004-09-07
Posted: 2005-12-01
Terminated: 2006-10-03
Recalling firm: Howmedica Osteonics Corp
Product: Long Length Dyax Nail.
Product code: NDH Nail, Fixation, Bone, Metallic
Reason for recall: Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm sent out notification letters via FedEx on 9/7/2004 with return receipt.
Quantity in commerce: 4
Distribution: The devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.
Product codes and lots: Catalog No. 1594-4430S Lot K559623

Product code NDH

K013468Class IILong Length Dyax NailHowmedica Osteonics Corp. / cleared 2001-11-16

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)