Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Summary
The FDA issued a Class II for Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labele by XTANT Medical Holdings, Inc. Reason: Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is inc.
Details
Source
Device Recall
External ID
Z-0846-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
Product Description
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Lot/Code Info: UDI-DI: 00810076564005, Lot: AP23000143
Quantity Affected: 6
Reason for Recall
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
Distribution
US distribution in MI.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
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 221 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-0846-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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