Ossur Lil Angel Vest P3 Sorbatex — Class II medical device recall Z-1515-2016
Terminated recall by Ossur H / F, reported 2016-04-27, distributed nationwide. There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
| Recall number | Z-1515-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur H / F, Reykjavik, N/A, Iceland |
| Recall initiated | 2016-03-14 |
| Classified | 2016-04-19 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2016-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK |
| Quantity | 435 all |
| Reason classes | device malfunction |
Product
Ossur Lil Angel Vest P3 Sorbatex. 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1515-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.