Recall Z-0553-2014 ยท MNI Orthosis, Spinal Pedicle Fixation
SpineFrontier, Inc.
PedFuse Reset Screw Inserters; PedFuse Screw Inserter 05-7 REset Part #11-80110 The PedFuse Screw Inserter 05-7 REset, Screw Inserter 05-7 REspond, and Screw Inserter 08-9 REset are used as a screw capture, screw driver, and screw insertion tool in the PedFuse system.
| Date | Dec 20, 2013 (initiated Nov 20, 2013) |
| Status | Terminated |
| Reason | Screw inserters may not mate properly with hex interface of the screws. |
| Root cause | Device Design |
| Action | The firm, SpineFrontier, Inc., sent an "Urgent PedFuse Screw Inserter Voluntary Recall Notification" letter on November 20, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to initiate the immediate return of the recalled products and to complete a recall ACKNOWLEDGEMENT FORM via fax or email to: SpineFrontier, Inc., 500 Cummings Center, Suite 3500, Beverly MA 01915, Attn: Customer Service; Fax: 978-232-3991; email: customerservice@spinefrontier.com. Please feel free to contact at 978-232-3990 Monday thru Friday |
| Quantity | 4 |
| Distribution | US Distribution to states of:Texas, New York, Illinois, Ohio, Virginia, Washington D.C., and Florida. . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc., Feb 15, 2013 |