FDA Device recall Z-0006-2025
Miami J Select Collar, Catalog: MJS-101
- FDA Device
- Class II
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class II recall of Miami J Select Collar, Catalog: MJS-101 by Ossur H F, citing pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually pee….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0006-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-08-20 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ossur H F |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA |
Product
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Reason
Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
Identifiers
| code_info | REF/UDI-DI/GTIN/Lot Range/Sold in the Period, Date Range: MJS-101/05690967817008/MX220516 to MX230104/2022-05-19 to 202…REF/UDI-DI/GTIN/Lot Range/Sold in the Period, Date Range: MJS-101/05690967817008/MX220516 to MX230104/2022-05-19 to 2023-06-05, MJSR-101/05690967817145/MX220516 to MX230104/2022-05-19 to 2023-06-05 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0006-2025%22
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