FDA-Device2018-05-02Class II
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Integra LifeSciences Corp.
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.
Sold states
US nationwide distribution.
Affected count
250
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1487-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief