FDA recall Z-0006-2025

Ossur H / F · Class II · device

Product

Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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.

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

Key facts

Status
Ongoing
Initiation date
2024-08-20
Report date
2024-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Reykjavik, N/A, Iceland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0006-2025