FDA Device recall Z-0380-2022
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
- FDA Device
- Class II
- terminated
- Published 2021-12-22
On 2021-12-22 the FDA classified a Class II recall of Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use by Ossur Americas, citing instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0380-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-09 |
| Published | 2021-12-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ossur Americas |
| Distribution | US |
Product
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Reason
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Identifiers
| code_info | Instructions for Use Rev. 3 2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Ossur Americas
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FDA Device · Class II · 2022-07-13 · Ossur Americas - OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine
FDA Device · Class II · 2021-06-23 · Ossur Americas - Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK
FDA Device · Class II · 2019-03-20 · Ossur Americas - Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERILE RING SML
FDA Device · Class II · 2019-03-20 · Ossur Americas
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0380-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.