Class II — Ossur Americas
| Recalling firm | OSSUR Americas |
|---|---|
| Registered facility | View this company's 8 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents. |
| Quantity | 410 devices |
| Distribution | Worldwide distribution including US nationwide (including Puerto Rico). |
| Initiated | 2022-05-30 |
| Classified | 2022-07-05 |
| Terminated | 2024-12-27 |
| Recall number | Z-1330-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ossur Americas (Z-1330-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90312/
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