TCC-EZ — Class II medical device recall Z-1487-2018
Terminated recall by Integra LifeSciences Corp., reported 2018-05-02, distributed nationwide. A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exother
| Recall number | Z-1487-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2017-08-18 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2018-07-19 |
| Distributed | Nationwide (US) |
| Quantity | 250 |
| Lot numbers | 1216033 |
| Model numbers | TCC2-4051 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1487-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.