Recall Z-0624-2014 ยท HXB Probe
SpineFrontier, Inc.
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
| Date | Jan 3, 2014 (initiated Sep 11, 2013) |
| Status | Terminated |
| Reason | Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications. |
| Root cause | Process change control |
| Action | On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax. |
| Quantity | 13 devices |
| Distribution | US Distribution: including states of: TX and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123164 | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM Spinefrontier, Inc., Feb 15, 2013 |