Recall Z-1482-2013 ยท HWA Impactor
SpineFrontier, Inc.
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
| Date | Jun 5, 2013 (initiated May 10, 2008) |
| Status | Terminated |
| Reason | During two separate occasions an impactor plate on the handle broke off while being struck by a mallet. |
| Root cause | Process design |
| Action | Firm states they notified consignees of recall between 5/10/08 and 5/22/2008. Zero product is currently in distribution. |
| Quantity | 10 |
| Distribution | Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.