Device product
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
Z-1665-2013
Product summary
- Event
- Event 65429
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 devices
- Official record key
device-enforcement:Z-1665-2013
Official wording
Reason: 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.
Code information: Lot/Serial Numbers: 47175
Distribution pattern: USA Nationwide Distribution including the states of: FL, TX, OK, MO, NJ, MA
Derived failure modes
-
Unknown
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.