XTANT Medical X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Brand
XTANT Medical
Lot Codes / Batch Numbers
X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
Products Sold
X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
XTANT Medical is recalling X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. due to The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Recommended Action
Per FDA guidance
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: mdolan@xtantmedical.com Fax: 1-406-388-3380 3. Return Affected Product Contact Michele Dolan at mdolan@xtantmedical.com, 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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, MI, NV, TX
Page updated: Jan 10, 2026