Integra LifeSciences Corp.: Medical Device Recall in 2018 - (Recall #: Z-1487-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 18, 2017

Date Posted: May 2, 2018

Recall Number: Z-1487-2018

Event ID: 79636

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.

Status: Terminated

Product Quantity: 250

Code Information:

Lot 1216033

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated