Recall Z-2054-2012 ยท MNI Orthosis, Spinal Pedicle Fixation
Synthes (USA) Products LLC
Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are in
| Date | Jul 20, 2012 (initiated May 31, 2012) |
| Status | Terminated |
| Reason | USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook, Medium, right). |
| Root cause | Employee error |
| Action | SYNTHES sent a Medical Device Recall letter dated May 31, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees and sales reps remove recalled product from their inventory, call the firm at 1-800-479-6329 to receive an authorization number and complete the enclosed verification form and return to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, Colorado 80132. If customers do not have any of the affected product they were instructed to complete the Verification Section at the end of |
| Quantity | 12 units |
| Distribution | Nationwide Distribution including GA, PA, SC, TX, and UT and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020517 | SYNTHES DUAL-OPENING USS Synthes (Usa), Apr 15, 2002 |