# FDA recall Z-1487-2018

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2017-08-18.

## 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

- **Recall number:** Z-1487-2018
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1487-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1487-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*