Z-0274-2014 Class II Terminated
FDA device recall Z-0274-2014 was initiated by SpineFrontier, Inc. on Aug 28, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Sep 13, 2018). Affected quantity: 67.
Recall details
- Product Type
- Devices
- Report Date
- Nov 20, 2013
- Initiation Date
- Aug 28, 2013
- Termination Date
- Sep 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67
Product 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.
Reason for recall
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.
Distribution pattern
Nationwide Distribution including FL, TX, OK, MO, IL, OH, VA, OR, CO, KS, CT
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0274-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026