Z-1665-2013 Class II Terminated
FDA device recall Z-1665-2013 was initiated by SpineFrontier, Inc. on May 24, 2013 and is designated Class II. Reason for recall: The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small. The recall status is terminated (terminated Oct 8, 2014). Affected quantity: 12 devices.
Recall details
- Product Type
- Devices
- Report Date
- Jul 10, 2013
- Initiation Date
- May 24, 2013
- Termination Date
- Oct 8, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 devices
Product description
S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA
Reason for recall
The outer sleeve would not fit over the S-LIFT Inserter assembly because the hole at the top of the sleeve handle was too small.
Distribution pattern
USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA
Code information
Lot/Serial Numbers: 47175
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1665-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026