FDA Enforcement
Class II
Ongoing
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Recall: Z-0006-2025
·
Reported October 9, 2024
Enforcement
- Recall Number
- Z-0006-2025
- Event ID
- 95278
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ossur H / F
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 9, 2024
- Initiation Date
- August 20, 2024
- Classification Date
- October 1, 2024
- Address
- Grjothals 5, N/A, Reykjavik, N/A, N/A, Iceland
Description
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.
Code Info
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
Distribution
US: NH, MA, NY, NJ, PA, GA, MD, NC, IN, FL, AR, TN, KY, OH, MI, IL, TX, MO, CO, UT, AZ, WA, OR, CA, NM, VA, IA, MN, NE, SC, MT, LA, ID, SD, AL, CT, OK, AK, PR
Quantity
21,020