FDAFDA · Food and drugs·Recall number Z-0006-2025
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Published October 9, 2024 · Recall initiated: August 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ossur H / F
- Distributor
- 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
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Iceland
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