—#38869

Product

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

FDA product code: NDH — Nail, Fixation, Bone, Metallic
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K034002
Affected lot / code info: Catalog 3220-0320S Lot K949408 3225-0360S, lot code K949396

Why it was recalled

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 (FDA determination)

Other

Action the firm took

Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.

Recalling firm

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

Distribution

Distribution pattern: The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.

Timeline

Recall initiated: 2004-11-22
Posted by FDA: 2005-12-01
Terminated: 2006-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #38869. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.