Recall Z-1351-2009
Stryker Howmedica Osteonics Corp. · initiated March 2, 2009
Product
Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.
Codes / lots: Catalog number LG3-OT, no lot numbers, this is the surgical technique brochure.
Reason for recall
Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails.
FDA-determined cause: Labeling design
Action taken
Stryker sent Urgent Product Recall letters by Federal Express on March 2, 2009 to Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. Letters were sent to all who have used the Gamma3 products in the past.
Details
- Recall number
- Z-1351-2009
- Initiated
- March 2, 2009
- Posted by FDA
- June 1, 2009
- Terminated
- August 17, 2012
- Product code
- JDS – Nail, Fixation, Bone
- Quantity
- 18232
- Distribution
- Nationwide.
- Recalling firm
- Stryker Howmedica Osteonics Corp., Mahwah, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1349-2009 | Stryker, Gamma3 Plus Obese Targeting System, Operative Technique for Hip Fracture…Operative Technique: further clarification and guidance is needed to help reduce the potential for distal… | 03/02/2009Terminated |
| Z-1350-2009 | Stryker, Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System.Operative Technique: further clarification and guidance is needed to help reduce the potential for distal… | 03/02/2009Terminated |