FDA-Device2023-01-18Class II
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
CoreLink LLC
Hazard
Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.
Sold states
US Nationwide distribution.
Affected count
18 units
Manufactured in
2072 Fenton Logistics Park, Fenton, MO, United States
Products
CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0954-2023Don't want to check this manually?
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