—#80216

Product

Stryker, Gamma3 Plus Obese Targeting System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.

FDA product code: JDS — Nail, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Catalog number LG3P-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 #80216. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.