Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plat

FDA device recall Z-1927-2013 · posted 2013-08-08 · Terminated

Recall details

Recalling firm

SpineFrontier, Inc.

Reason for recall

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.

Root cause

Device Design

Status

Terminated

Product code

HXX

Quantity affected

12 devices

Distribution

Nationwide Distribution including Texas, Ohio, and Missouri.

Date initiated

2013-05-10

Date posted

2013-08-08

Date terminated

2015-07-20

Location

Beverly, MA