—#38874

Product

Long Length Dyax Nail.

FDA product code: NDH — Nail, Fixation, Bone, Metallic
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K013468
Affected lot / code info: Catalog No. 1594-4430S Lot K559623

Why it was recalled

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 (FDA determination)

Other

Action the firm took

The firm sent out notification letters via FedEx on 9/7/2004 with return receipt.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: The devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.

Timeline

Recall initiated: 2004-09-07
Posted by FDA: 2005-12-01
Terminated: 2006-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.