Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
This recall has been terminated (originally issued December 1, 2005).
- Recall Initiated
- November 22, 2004
- Posted
- December 1, 2005
- Terminated
- October 3, 2006
- Recall Number
- Z-0241-06
- Quantity
- 19
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.
Lot / Code Info
Catalog 3220-0320S Lot K949408 3225-0360S, lot code K949396
Root Cause
Other
Action Taken
Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.