Device product
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.
Z-1664-2013
Product summary
- Event
- Event 65432
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-1664-2013
Official wording
Reason: The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
Code information: Lot/Serial Numbers: 7201.007 and 7201.007-1
Distribution pattern: USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.
Derived failure modes
-
Unknown
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.