Recall Z-0006-2025— Ossur H / F
Class II · Ongoing
Class II FDA medical device recall by Ossur H / F, initiated 2024-08-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Ossur H / F
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-08-20
- Firm location
- Reykjavik, N/A, Iceland
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.