# FDA recall Z-1513-2021

> **DJ Orthopedics de Mexico S.A. de C.V.** · Class II · device recall initiated 2021-04-12.

## Product

DONJOY REF:11-0472-9 ULTRASLING PRO ER/IR 30, UNIVERSAL, Rx ONLY, UDI: (01)00190446683674 - Product Usage:  intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

## Reason for recall

failed rivet at the chafe tab of arm sling.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, France, Germany, Japan, Poland, United Kingdom.

## Key facts

- **Recall number:** Z-1513-2021
- **Recalling firm:** DJ Orthopedics de Mexico S.A. de C.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-12
- **Report date:** 2021-05-05
- **Termination date:** 2024-03-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tijuana, N/A, Mexico

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1513-2021

## Citation

> AI Analytics. FDA recall Z-1513-2021. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1513-2021. Source: US FDA. Licensed CC0.

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