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Bunion Bootie
SLO LIVING LLC · Model LargeRight · UDI-DI 04518227081925
8
510(k) clearances
2
Adverse events
3
Recalls
97
Facilities
Description
Soft, ultra-thin, flexible orthotic for bunions (hallux valgus). The full coverage toe hood covers the big toe and is secured with a heel strap.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-02-25 | Cardinal Health 200, LLC | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent th |
| 2021-02-25 | Cardinal Health 200, LLC | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent th |
| 2021-02-25 | Cardinal Health 200, LLC | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent th |
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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.