Recall Z-0544-2014 ยท MNI Orthosis, Spinal Pedicle Fixation
SpineFrontier, Inc.
PedFuse Reset Screw; Model: 01-80115-55 The PedFuse Reset pedicle screw implants intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
| Date | Dec 19, 2013 (initiated Oct 18, 2013) |
| Status | Terminated |
| Reason | During routine servicing, it was discovered that one 8mmx55mm Reset screw was assembled with an 8mm tulip head and a 9mm screw. The implant should have consisted of an 8mm tulip head and an 8mm screw. A recall was initiated to remove all remaining screws of the same lot from the field to investigate the nonconformity. |
| Root cause | Software design (manufacturing process) |
| Action | SpineFrontier sent an Voluntary Recall Notification dated November 5,2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. All affected implants are to be returned to SpineFrontier for inspection. SpineFrontier is requiring confirmation that you have received this notice and that you will initiate the immediate return of the implants listed above. IMMEDIATE RESPONSE REQUIRED. Please feel free to contact us at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions |
| Quantity | 35 Devices |
| Distribution | US Distribution to VA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc., Feb 15, 2013 |