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U.S. Department of Health and Human Services

Class 2 Device Recall XTANT Medical Holdings, Inc

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 Class 2 Device Recall XTANT Medical Holdings, Incsee related information
Date Initiated by FirmAugust 21, 2024
Date PostedOctober 17, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0125-2025
Recall Event ID 95395
510(K)NumberK221403 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductCortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Code Information UDI-DI: 00810076563190, Lot: DNI
FEI Number 3005031160
Recalling Firm/
Manufacturer		 XTANT Medical Holdings, Inc
664 Cruiser Ln
Belgrade MT 59714-9719
For Additional Information Contact
937-847-8400
Manufacturer Reason
for Recall		Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.
FDA Determined
Cause 2		Process change control
ActionOn 8/21/24, recall notices were mailed and emailed to customers who were asked to do the following: 1) Examine affected devices and quarantine any screws with DNI markings. 2) Notify your staff about the recall. If affected devices were further distributed, provide the recall notice to these customers. 3) Complete and return the response forms via email to mdolan@xtantmedical.com
Quantity in Commerce330
DistributionUS Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Total Product Life CycleTPLC 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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NKB
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