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SpineFrontier, Inc. recalls S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which h
Recalled November 20, 2013 · FDA recall Z-0274-2014 · SpineFrontier
Hazard
Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades. · FDA Class II
Units
67
Sold at
Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
Description
Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The firm's investigation revealed that extension shims may not fit down all retractor blades.
Product
S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curved, rectangular slabs which have four protrusions used for ratcheting. They come in straight and pointed varieties, either with or without a tab containing an additional bend. Extension shims are designed to slide down retractor blades, and are optional retractor components utilized during lumbar interbody fusion procedures. They are intended to manipulate tissue and prevent tissue from interfering inside the surgical field.
Manufacturer(s)
SpineFrontier, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →