Recall Z-1957-2013 ยท HXX Screwdriver
SpineFrontier, Inc.
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
| Date | Aug 13, 2013 (initiated May 9, 2012) |
| Status | Terminated |
| Reason | The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. |
| Root cause | Device Design |
| Action | On May 9, 2012 an email was sent to consignees requesting that the product be returned for servicing and that a replacement part would be sent. |
| Quantity | 9 |
| Distribution | Distributed in DC and the states of MA, and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121060 | SPINE FRONTIER INDUS ACP SYSTEM Spinefrontier, Inc., Jul 3, 2012 |