Device product
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0006-2025
Product summary
- Firm
- Ossur H / F
- Event
- Event 95278
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21,020
- Official record key
device-enforcement:Z-0006-2025
Official wording
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 information: 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 pattern: 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
Derived failure modes
-
Unknown
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.