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U.S. Department of Health and Human Services

Class 2 Device Recall Invue Split Driver, Assembly with Handle

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 Class 2 Recall
Invue Split Driver, Assembly with Handle
see related information
Date Posted August 08, 2013
Recall Status1 Open
Recall Number Z-1927-2013
Recall Event ID 65444
Product Classification Screwdriver - Product Code HXX
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.
Code Information Lot/Serial Numbers: 027104, 027105
Recalling Firm/
Manufacturer
SpineFrontier, Inc.
500 Cummings Ctr Ste 3500
Beverly, Massachusetts 01915-6516
Consumer Instructions Problem is exhibited on insertion. Device, after successful implantation, should perform as intended.
For Additional Information Contact Helen Moon
978-232-3990
Manufacturer Reason
for Recall
Device design.
FDA Determined
Cause 2
DESIGN: 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/ 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.
Quantity in Commerce 12 devices
Distribution Nationwide Distribution including Texas, Ohio, and Missouri.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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