Recall Z-1016-2009 ยท MNI Orthosis, Spinal Pedicle Fixation
Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511. The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use f
| Date | Mar 12, 2009 (initiated Oct 31, 2008) |
| Status | Terminated |
| Reason | The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation. |
| Root cause | Process control |
| Action | Hospital risk managers and implanting physicians were notified separately by letters dated 1/9/09. The letters advised of the recall, reported that a firm representative would visit the facility to pick up the recalled products. Physicians were instructed to closely monitor their patients during postoperative visits, to notify any other physician who may be monitoring the patient in lieu of the implanting physician, and to advise their patients to contact them immediately if they have any sudden and significant symptoms (increased discomfort, sudden change in their clinical symptoms, or new |
| Quantity | 446 |
| Distribution | Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072317 | MODIFICATION TO:TSRH SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc., Sep 18, 2007 |