Z-1665-2013 Class II Terminated

Recalled by SpineFrontier, Inc. — Beverly, MA

Recall Details

Product Type
Devices
Report Date
July 10, 2013
Initiation Date
May 24, 2013
Termination Date
October 8, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 devices

Product Description

S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA

Reason for Recall

The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.

Distribution Pattern

USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA

Code Information

Lot/Serial Numbers: 47175