Home › Manamed, Inc. › ManaEZ Thumb Spica Right, Extra Large
ManaEZ Thumb Spica Right, Extra Large
Manamed, Inc. · Model EZTS3809R-XL · UDI-DI 00810113684147
10
510(k) clearances
48
Adverse events
1
Recalls
428
Facilities
Description
The ManaEZ Thumb Spica is an orthosis that includes our patent pending pull system. Low-profile, high-quality lace design system Extra-large size to accommodate patients who do not fit the one-size-fits-most orthosis.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-18 | North Coast Medical Inc | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. |
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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.