FDAClass IIJanuary 18, 2023

CoreLink LLC recall

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

Why was CoreLink LLC recalled?

Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI M725AT32080, Lot Codes: SM135217, SM129260

Product
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Recalling firm
CoreLink LLC
Quantity
18 units
Distribution
US Nationwide distribution.
Recall date
January 18, 2023
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls