Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Summary
The FDA issued a Class II for Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-650 by XTANT Medical Holdings, Inc. Reason: Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released man.
Details
Source
Device Recall
External ID
Z-0125-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Lot/Code Info: UDI-DI: 00810076563190, Lot: DNI
Quantity Affected: 330
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.
Distribution
US Nationwide distribution in the states of IL, WI, FL, PA, CA, TX, MI, MO, VA, OH, MA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-21
Company
Belgrade, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 180 device recalls issued in the same week, part of 403 device-related FDA actions this month.
XTANT Medical Holdings, Inc has 6 FDA actions in our database, including 5 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (XTANT Medical Holdings, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does XTANT Medical Holdings, Inc have FDA actions?
XTANT Medical Holdings, Inc has 6 FDA actions in our database, including 5 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0125-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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