Reported Jan 18, 2023 · Terminated

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

CoreLink LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CoreLink LLC · 2072 Fenton Logistics Park · Fenton, MO · 63026-2504

Is this the product you have?

  • CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE
  • REFAT3208
Lot codes and dates
  • UDI/DI M725AT32080
  • Lot Codes
    • SM135217
    • SM129260
Amount recalled
18 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 20, 2024 · Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.