LEONE SPA
LEONE SPA · Model K7321-10 · UDI-DI 08033707067207
ECI
Prescription
10
510(k) clearances
18
Adverse events
3
Recalls
121
Facilities
Description
LIGATURES MINI modules TRANSPARENT SMALL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-21 | G & H Wire Company | Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy |
| 2021-01-21 | G & H Wire Company | The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the dev |
| 2011-08-18 | Biomet Microfixation, Inc. | On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". |
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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.