Recall Z-0866-2014 ยท HXX Screwdriver
Medtronic Sofamor Danek USA Inc
SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
| Date | Jan 30, 2014 (initiated Jan 3, 2014) |
| Status | Terminated |
| Reason | 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 | Reprocessing Controls |
| Action | The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included, on 01/03/2014. |
| Quantity | 7 units |
| Distribution | US Distribution in the states of CA, NC, TX, IN, NJ, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.