# FDA recall Z-0380-2022

> **Ossur Americas** · Class II · device recall initiated 2021-11-09.

## Product

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

## Reason for recall

Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

## Distribution

US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.

## Key facts

- **Recall number:** Z-0380-2022
- **Recalling firm:** Ossur Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-09
- **Report date:** 2021-12-22
- **Termination date:** 2023-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Foothill Ranch, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0380-2022

## Citation

> AI Analytics. FDA recall Z-0380-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0380-2022. Source: US FDA. Licensed CC0.

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