Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Stryker, Gamma3, The Compact Version of the Gamma Nail System, Operative Technique for Hip Fracture System, Trochanteric and Long Nails.

FDA Recall Z-1351-2009 · Posted 2009-06-01

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDS
Date Initiated2009-03-02
Date Terminated2012-08-17
Product Quantity18232

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.

Firm Action

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.

Root Cause

Labeling design

Distribution Pattern

Nationwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑