Recalls / —
—#80217
Product
Stryker, Gamma3S Trochanteric Nail 170, Operative Technique for Hip Fracture System.
- FDA product code
- JDS — Nail, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- Affected lot / code info
- Catalog number LG3S-OT, no lot numbers, this is the surgical technique brochure.
Why it was recalled
Operative Technique: further clarification and guidance is needed to help reduce the potential for distal mis-drilling of the short Gamma3 Trochanteric Nails.
Root cause (FDA determination)
Labeling design
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430
Distribution
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2009-03-02
- Posted by FDA
- 2009-06-01
- Terminated
- 2012-08-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #80217. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.