FDA-Device2013-11-20Class II
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
SpineFrontier, Inc.
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.
Sold states
Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
Affected count
67
Manufactured in
500 Cummings Ctr Ste 3500, Beverly, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0274-2014Don't want to check this manually?
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