SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manua
FDA device recall Z-0866-2014 · posted 2014-01-30 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- 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.
- Action taken
- The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included, on 01/03/2014.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 7 units
- Distribution
- US Distribution in the states of CA, NC, TX, IN, NJ, and MI.
- Date initiated
- 2014-01-03
- Date posted
- 2014-01-30
- Date terminated
- 2014-05-16
- Location
- Memphis, TN
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