Recall Z-0533-2022 ยท PEK Spinous Process Plate
XTANT Medical
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
| Date | Dec 29, 2021 |
| Status | Terminated |
| Reason | The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert. |
| Root cause | Under Investigation by firm |
| Action | On 12/30/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via FedEx Priority Overnight (Direct Signature Required) to its distributes to notify their customer that a specific lot of their interspinous fusion systems were manufactured out of tolerance resulting in the distal end of the crossbar not properly engaging with the inserts. Customer are instructed to: 1. Immediately examine their inventory and quarantine any affected products subject to this recall. 2. Complete the enclosed Acknowledgement Form, even if customers have no remaining devices in their inventory, and return t |
| Quantity | 24 devices |
| Distribution | U.S.: CA, MI, NV, and TX O.U.S.: Portugal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130438 | AXLE INTERSPINOUS FUSION SYSTEM X-Spine Systems, Inc., Jun 27, 2013 |