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Transtibial Exhaust Valve active.valve
Streifeneder ortho.production GmbH · Model 6P50 · UDI-DI 04048817574976
1
510(k) clearances
11
Adverse events (2 deaths)
1
Recalls
16
Facilities
Description
Transtibial Exhaust Valve active.valve, to secure the prosthesis within the socket by vacuum, Aluminium
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-06-23 | Ossur Engineering, Inc | The plastic caps have come off or become loose when the user stepped into their prosthesis. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.