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Integra LifeSciences Corp. recalls TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Recalled May 2, 2018 · FDA recall Z-1487-2018 · Integra LifeSciences
Hazard
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. · FDA Class II
Units
250
Sold at
US nationwide distribution.
Description
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.
Product
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →