Ossur H / F: Device Recall
Recall #Z-0006-2025 · 08/20/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0006-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Ossur H / F
- Status
- Ongoing
- Date Initiated
- 08/20/2024
- Location
- Reykjavik, N/A, Iceland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,020
Reason for Recall
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.
Product Description
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.