Recall Z-0134-2016 ยท MNI Orthosis, Spinal Pedicle Fixation
Synthes (USA) Products LLC
5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
| Date | Oct 17, 2015 (initiated Sep 4, 2015) |
| Status | Terminated |
| Reason | This product was produced using a finishing process not identified as part of the manufacturing specification. The process used with the lots subject to this Recall was a bead blast process. (Bead Blasting vs. Shot Peened). |
| Root cause | Process control |
| Action | An Urgent Notice: Medical Device Recall, dated September 4, 2015, was sent to end users to alert them about the issue and possible risk to patients. Customers were requested to follow the actions to be taken for if they have affected product or not; complete the response form, and return affected product. Customers can call 610-719-5450 or a local Synthes Sales Consultant with any questions. |
| Quantity | 492 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020517 | SYNTHES DUAL-OPENING USS Synthes (Usa), Apr 15, 2002 |