Recall Z-0412-2013 ยท KWP Appliance, Fixation, Spinal Interlaminal
SpineFrontier, Inc.
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.
| Date | Nov 21, 2012 (initiated Aug 28, 2012) |
| Status | Terminated |
| Reason | Inspan Compressors may break at weld causing a loss of compression |
| Root cause | Device Design |
| Action | Spine Frontier issued e-mail notices to customers on May 14, 2012 advising of the potential for breakage. Units were replaced with weld free design. |
| Quantity | 17 units |
| Distribution | Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093438 | PARADIGM INTERSPINOUS FUSION PLATE Paradigm Spine, LLC, Oct 6, 2010 |