FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
- Recall number
- Z-0241-06
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
- Status
- Terminated
- Initiated
- 2004-11-22
- Posted
- 2005-12-01
- Terminated
- 2006-10-03
- Reason
- 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
- Other
- Action
- Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.
- Quantity
- 19
- Distribution
- The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.
- Lot, serial or model codes
- Catalog 3220-0320S Lot K949408 3225-0360S, lot code K949396
- 510(k) numbers
- ["K034002"]
- PMA numbers
- not on file
- Product code
- NDH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28