X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Recall
- Recall Number
- Z-0533-2022
- Event Number
- 89367
- Firm
- XTANT Medical
- FEI Number
- 3005031160
- Product Code
- PEK
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 29, 2021
- Terminated
- June 17, 2024
- Address
- 664 Cruiser Ln, Belgrade, MT, 59714-9719
Description
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
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 the completed Acknowledgment Form to the attention of Michele Dolan via: Mail: Xtant Medical Axle Interspinous Fusion System Recall 664 Cruiser Lane Belgrade, MT 59714 Email: [email protected] Fax: 1-406-388-3380 3. Return Affected Product Contact Michele Dolan at [email protected], or 1-406-388-0480 ext. 1127, between 8 a.m. and 5 p.m. (Mountain Time) to obtain instructions for returning affected product, and to obtain replacement devices, as applicable, which will be provided at no cost to you. 4. Package the affected products to be returned. Xtant will provide a shipping container (if needed) with a return shipping label. Securely package the affected product(s). Send the container at your earliest opportunity to: ATTN: Axle Interspinous Fusion Recall RA# 21-xxxx Xtant Medical 732 Cruiser Lane Belgrade, MT 59714 5. To Inform all their staff members of this recall and if affected products have been further distributed to contact all customers. For any questions contact the Director of Regulatory Affairs/Quality Assurance at 1-406-388-0480 ext. 1125 from 8 a.m. to 5 p.m. (Mountain Time).
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24 devices