FDA Device recall Z-1487-2018
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 by Integra Lifesciences, citing 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 pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1487-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-18 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Reason
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.
Identifiers
| code_info | Lot 1216033 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1487-2018%22
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