Recall Z-1935-2013 ยท MNI Orthosis, Spinal Pedicle Fixation
Synthes USA HQ, Inc.
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 pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
| Date | Aug 9, 2013 (initiated Jun 5, 2013) |
| Status | Terminated |
| Reason | DePuy Synthes has issued a Medical Device Correction notice for the 5.0mm Stainless Steel rods. This product was produced using a finishing process not identified as part of the manufacturing specification. No adverse event reports associated with the use of this product were received, and an extensive engineering and medical safety review concluded that the product poses no incremental risk to t |
| Root cause | Nonconforming Material/Component |
| Action | On June 5, 2013, De Puy Synthes notified by letter the direct acc acccounts which were identified to have received 5.0mm stainless steel rods and requested return of the product by calling 1-800-479-6329 to obtain a return authorization number. Completion of the verification section of the letter, including negative responses was also requested. |
| 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 |