# FDA recall Z-0646-2022

> **Oscor Inc.** · Class II · device recall initiated 2021-12-22.

## Product

Destino Twist 14F (also branded as Guidestar 14F)

## Reason for recall

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

## Distribution

Distribution to TN and PA in USA    OUS distribution to Czech Republic

## Key facts

- **Recall number:** Z-0646-2022
- **Recalling firm:** Oscor Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2021-12-22
- **Report date:** 2022-02-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0646-2022

## Citation

> AI Analytics. FDA recall Z-0646-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0646-2022. Source: US FDA. Licensed CC0.

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