Recall Z-1927-2013 ยท HXX Screwdriver
SpineFrontier, Inc.
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.
| Date | Aug 8, 2013 (initiated May 10, 2013) |
| Status | Terminated |
| Reason | Device design. |
| Root cause | Device Design |
| Action | SpineFrontier sent an URGENT Advisory Notice dated June 27, 2013, to all affected consignees regarding the use of Invue Drivers. The notice advises users that the Split Tip Stylet Driver Assembly (11-70099) and Sold Driver, AO Connection (11-70070 or 11-70077) are being shipped in place of the Split Driver Assembly w/Handle (SI70006). The uses of the replacement parts are explained. Consignees are instructed to complete the Acknowledgement Form and return it to SpineFrontier. On June 28, 2013, customers were sent a second Advisory Notice requesting the removal of the Split Driver Assy w/ Ha |
| Quantity | 12 devices |
| Distribution | Nationwide Distribution including Texas, Ohio, and Missouri. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.