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.
Enforcement
- Recall Number
- Z-0274-2014
- Event ID
- 65760
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- SpineFrontier, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- November 20, 2013
- Initiation Date
- August 28, 2013
- Classification Date
- November 14, 2013
- Termination Date
- September 13, 2018
- Address
- 500 Cummings Ctr Ste 3500, Beverly, MA, 01915-6516, United States
Description
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.
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.
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
Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
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