Z-1664-2013 Class II Terminated
FDA device recall Z-1664-2013 was initiated by SpineFrontier, Inc. on May 17, 2013 and is designated Class II. Reason for recall: The S-LIFT Instrument Case contained a bracket with peeling nylon coating. The recall status is terminated (terminated May 17, 2016). Affected quantity: 12.
Recall details
- Product Type
- Devices
- Report Date
- Jul 10, 2013
- Initiation Date
- May 17, 2013
- Termination Date
- May 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
Product description
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
Reason for recall
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
Distribution pattern
USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
Code information
Lot/Serial Numbers: 7201.007 and 7201.007-1
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1664-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026