Integra LifeSciences Corp. recalls TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
- Recall date
- August 18, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1487-2018
- FDA classification
- Class II
- Brand / firm
- Integra LifeSciences Corp.
- Sold / distributed
- US nationwide distribution.
Why it was recalled
A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
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