# FDA recall Z-1690-2019

> **Exactech, Inc.** · Class II · device recall initiated 2019-04-26.

## Product

Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90

## Reason for recall

The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.

## Distribution

OK, VA, FL

## Key facts

- **Recall number:** Z-1690-2019
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-26
- **Report date:** 2019-06-05
- **Termination date:** 2021-04-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2019

## Citation

> AI Analytics. FDA recall Z-1690-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1690-2019. Source: US FDA. Licensed CC0.

---

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