FDA recall Z-1487-2018

Product

TCC-EZ, Total Contact Cast System, Model No. TCC2-4051

Reason for recall

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.

Distribution

US nationwide distribution.

Key facts

Status

Terminated

Initiation date

2017-08-18

Report date

2018-05-02

Termination date

2018-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1487-2018