CoreLink FLXFIT 15 Implants May Use Stainless Steel Instead of Titanium

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Contact the company & request your remedy

Recalling firmCoreLink LLC2072 Fenton Logistics Park · Fenton, MO 63026-2504

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

CoreLink is recalling specific FLXFIT 15 implants that might use stainless steel instead of titanium. This could cause allergic reactions or other health issues for users.

Why it’s dangerous

The implants may contain stainless steel instead of the specified titanium alloy. This difference in material could lead to allergic reactions or other health issues for users.

Who’s affected

People who own or use the recalled FLXFIT 15 implants with lot codes SM135217 or SM129260 are most at risk. These implants are used for medical purposes.

How to tell if you have this one

Check for lot codes SM135217 or SM129260 on the implant packaging. The product has a unique reference code AT3208 and is labeled as FLXFIT 15, 32MM X 8MM, CAGE.

Brand
CoreLink
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Code
Look for lot codes SM135217 or SM129260 on the implant packaging.

✎ GovInfoNow

Questions people ask

What is the specific problem with these implants?

The implants may contain stainless steel instead of the specified titanium alloy.

How can I tell if I have a recalled implant?

Check for lot codes SM135217 or SM129260 on the implant packaging.

What should I do if I have a recalled implant?

The recall record does not specify a remedy, so contact CoreLink LLC for further instructions.

Take action

Contact CoreLink

We’ve drafted a message you can send CoreLink to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0954-2023 — CoreLink CoreLink

Hello,

I own a CoreLink that is covered by recall Z-0954-2023 from CoreLink.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0954-2023 (October 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0954-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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

Lower-risk recall