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

FDA Recall #Z-0954-2023 — Class II — October 20, 2022

Recall #Z-0954-2023 Date: October 20, 2022 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

CoreLink LLC — Fenton, MO

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

18 units

Distribution

US Nationwide distribution.

Code Information

UDI/DI M725AT32080, Lot Codes: SM135217, SM129260

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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