Recall Z-1896-2021— Ossur Americas
Class II · Terminated
Class II FDA medical device recall by Ossur Americas, initiated 2021-06-01, terminated 2023-06-22. FDA's recall record names no specific 510(k) clearance for this event. Product: OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101. Reason: Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine..
- Recalling firm
- Ossur Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-01
- Terminated
- 2023-06-22
- Firm location
- Foothill Ranch, CA, United States
Product description
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
Reason for recall
Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, which may lead to increased range of motion in the cervical spine.
Data sourced from openFDA. This site is unofficial and independent of the FDA.