Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1513-2016 — Ossur Lil Angel Vest P3 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

U.S. FDA — Device Enforcement · Iceland · 2016-03-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1513-2016
Date of alert
2016-03-14
Country / jurisdiction
Iceland
Risk level
Class II
Risk type
recall
Brand
Ossur H / F
Product category
device
Product type
Devices
Reported risk: There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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