Summary
The FDA issued a Class II for CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 by CoreLink LLC. Reason: Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium all.
Details
Source
Device Recall
External ID
Z-0954-2023
Action Date
2023-01-18
Status
Terminated
Category
device
Product Description
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Lot/Code Info: UDI/DI M725AT32080, Lot Codes: SM135217, SM129260
Quantity Affected: 18 units
Reason for Recall
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-20
Company
Fenton, MO
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 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
CoreLink LLC has 12 FDA actions in our database, including 1 recall and 11 clearances.
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 (CoreLink LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CoreLink LLC have FDA actions?
CoreLink LLC has 12 FDA actions in our database, including 1 recall and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0954-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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