Recall Z-1933-2013 ยท FSM Tray, Surgical, Instrument
SpineFrontier, Inc.
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of screws. O4.2mm Self-Drilling, O4.2mm Self-Tapping, and O4.5mm Self-Tapping screws
| Date | Aug 8, 2013 (initiated Jun 21, 2013) |
| Status | Terminated |
| Reason | Difficulty removing screws from the Invue caddies. |
| Root cause | Device Design |
| Action | SpineFrontier sent a Urgent Invue Caddy Advisory letter dated July 10, 2013, to all affected customers. Customers were advised the removal of the Invue Screw Caddy, SI70097 from the field for modification. Customers were asked to return the parts to SpineFrontier and to complete an Acknowledgement Form indicating that they have read the notice and will initiate the immediate return of the parts noted above. Please feel free to contact us at (978) 232-3990. On 8/21/2013 the recall was expanded. |
| Quantity | 13 |
| Distribution | Worldwide Distribution - USA, including the states of CT, VA, MA, FL, TX, CO and MS. and the country of Jamaica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121060 | SPINE FRONTIER INDUS ACP SYSTEM Spinefrontier, Inc., Jul 3, 2012 |