Device product
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Z-0412-2013
Product summary
- Event
- Event 63144
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-0412-2013
Official wording
Reason: Inspan Compressors may break at weld causing a loss of compression
Code information: Lot Numbers: SFP02323, SFP02323R, and SFP02323RR
Distribution pattern: Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
Derived failure modes
-
Unknown
Inspan Compressors may break at weld causing a loss of compression