Recall Z-1927-2013
SpineFrontier, Inc. · initiated May 10, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot/Serial Numbers: 027104, 027105
Reason for recall
Device design.
FDA-determined cause: Device Design
Action taken
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/ Handle Part Number SI70006 Lot Numbers 027104 and 027105. Consignees were instructed to complete the Acknowledgement Form and return it to SpineFrontier. Consignees with questions were instructed to call 978-232-3990.
Details
- Recall number
- Z-1927-2013
- Initiated
- May 10, 2013
- Posted by FDA
- August 8, 2013
- Terminated
- July 20, 2015
- Product code
- HXX – Screwdriver
- Quantity
- 12 devices
- Distribution
- Nationwide Distribution including Texas, Ohio, and Missouri.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA