Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Axle Interspinous Fusion System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Axle Interspinous Fusion System see related information
Date Initiated by Firm December 29, 2021
Create Date January 28, 2022
Recall Status1 Completed
Recall Number Z-0533-2022
Recall Event ID 89367
510(K)Number K130438  
Product Classification Spinous process plate - Product Code PEK
Product X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Code Information X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
Recalling Firm/
Manufacturer		 XTANT Medical
664 Cruiser Ln
Belgrade MT 59714-9719
For Additional Information Contact Michele Dolan
406-813-4145
Manufacturer Reason
for Recall		 The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
FDA Determined
Cause 2		 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 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).
Quantity in Commerce 24 devices
Distribution U.S.: CA, MI, NV, and TX O.U.S.: Portugal
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = PEK and Original Applicant = X-SPINE SYSTEMS, INC.
-
-