Miami J Select Collar — Class II medical device recall Z-0380-2022
Terminated recall by Ossur Americas, reported 2021-12-22, distributed nationwide. Instructions for use were updated to include additional information to facilitate the selection and use of the
| Recall number | Z-0380-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur Americas, Foothill Ranch, CA, United States |
| Recall initiated | 2021-11-09 |
| Classified | 2021-12-15 |
| Reported by FDA | 2021-12-22 |
| Terminated | 2023-12-18 |
| Distributed | Nationwide (US) |
| Model numbers | MJS-101, MJSR-101 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0380-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.