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
SM135217SM129260
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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