Recall Z-1510-2016— Ossur H / F
Class II · Terminated
Class II FDA medical device recall by Ossur H / F, initiated 2016-03-14, terminated 2016-08-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.. Reason: There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest..
- Recalling firm
- Ossur H / F
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-14
- Terminated
- 2016-08-16
- Firm location
- Reykjavik, N/A, Iceland
Product description
Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
Reason for recall
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Data sourced from openFDA. This site is unofficial and independent of the FDA.