21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves… — Class II medical device recall Z-0827-2019
Terminated recall by Ottobock Orthopedic Industrie, reported 2019-02-20, distributed nationwide. Some of the installed valve-inserts have a diameter smaller than the specification.
| Recall number | Z-0827-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ottobock Orthopedic Industrie, Duderstadt, N/A, Germany |
| Recall initiated | 2019-01-10 |
| Classified | 2019-02-13 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2021-06-22 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
Product
21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
Reason for recall
Some of the installed valve-inserts have a diameter smaller than the specification.
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-0827-2019. 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.