OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis — Class II medical device recall Z-1330-2022
Terminated recall by Ossur Americas, reported 2022-07-13, distributed nationwide. Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations
| Recall number | Z-1330-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ossur Americas, Foothill Ranch, CA, United States |
| Recall initiated | 2022-05-30 |
| Classified | 2022-07-05 |
| Reported by FDA | 2022-07-13 |
| Terminated | 2024-12-27 |
| Distributed | Nationwide (US) |
| Quantity | 410 devices |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 05690977241251, 05690977241282, 05690977241312, 05690977241343, 05690977241374, 05690977241404, 05690977387201, 05690977387218, 05690977387225, 05690977387232, 05690977387249, 05690977387256, 05690977387263, 05690977387270, 05690977387287, 05690977387294, 05690977387300, 05690977387317, 05690977387324, 05690977387331, 05690977387348, 05690977387355, 05690977387362, 05690977387379, 05690977387386 and 17 more |
Product
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Reason for recall
Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.
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-1330-2022. 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.