Recall Z-3044-2011 ยท KWP Appliance, Fixation, Spinal Interlaminal
Medtronic Sofamor Danek USA Inc
TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA. Product Usage: TSRH(R) Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumber, and/or sacral spine.
| Date | Aug 19, 2011 (initiated Jul 12, 2011) |
| Status | Terminated |
| Reason | Screws are 5 mm longer than the size etched on the screw. |
| Root cause | Error in labeling |
| Action | On 07/12/2011, the recalling firm, Medtronic notified the Sales Managers and Sales Force by conference call and email regarding the imminent notification and follow-up activities. A "VOLUNTARY RECALL" notification letter was sent to Risk Managers and Sales Representatives on 07/13/2011 with a delivery date of 07/14/2011. The letter states to immediately remove the recalled product from use and return to Medtronic. The letter includes a questionnaires form to be completed and returned as per the instructions. If appropriate, personal follow up with Sales Representatives will be made to ass |
| Quantity | 17 units |
| Distribution | Nationwide Distribution (USA) including the states of: OH, NY, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K984522 | MODIFICATION OF TSRH SPINAL SYSTEM Danek Medical, Inc., Jan 6, 1999 |