# FDA recall Z-1562-2022

> **DeRoyal Industries Inc** · Class II · device recall initiated 2022-07-15.

## Product

DeRoyal limb holders:    (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124;  (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125;  (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and  (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric,  University, REF M8137.

## Reason for recall

The webbing strap was laced improperly through the teeth of the buckle allowing the webbing strap to slide and was, therefore, not secure.

## Distribution

US Nationwide distribution in the states of FL, IN, NV, RI, TN, TX, and WV.

## Key facts

- **Recall number:** Z-1562-2022
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-07-15
- **Report date:** 2022-08-31
- **Termination date:** 2024-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1562-2022

## Citation

> AI Analytics. FDA recall Z-1562-2022. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1562-2022. Source: US FDA. Licensed CC0.

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