Stryker Howmedica Osteonics Corp. Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Catalog 3220-0320S Lot K949408 3225-0360S, lot code K949396
Products Sold
Catalog 3220-0320S Lot K949408 3225-0360S, lot code K949396
Stryker Howmedica Osteonics Corp. is recalling Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail. due to The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured wi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026