Recalls / —
—#124978
Product
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
- FDA product code
- HXX — Screwdriver
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- TI13J01811
Why it was recalled
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
Root cause (FDA determination)
Reprocessing Controls
Action the firm took
The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included, on 01/03/2014.
Recalling firm
- Firm
- Medtronic Sofamor Danek USA Inc
- Address
- 1800 Pyramid Place, Memphis, Tennessee 38132
Distribution
- Distribution pattern
- US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
Timeline
- Recall initiated
- 2014-01-03
- Posted by FDA
- 2014-01-30
- Terminated
- 2014-05-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #124978. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.