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Recall Observatory FDA recall evidence

Device 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.

Z-0274-2014

August 28, 2013

Class II

Product summary

Firm
SpineFrontier, Inc.
Event
Event 65760
Status
Terminated
Classification
Class II
Quantity
67
Official record key
device-enforcement:Z-0274-2014

Official wording

Reason: 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.

Code information: Part Number/Lot Number: 11-50109 43092R; 11-50109 46415; 11-50109 CT12H013; 11 -50109-1 46415-1; 11-50110 43089; 11-50110 43089R; 11-50110 46416; 11-50110-1 46416-1

Distribution pattern: Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.