International safety notice
Lima endodóntica rotativa/recíproca de un solo uso EdgeFile X7, EdgeGlidePath, EdgeOne Fire, EdgeOne Fire GlidePath, EdgeTaper y EdgeTaper Platinum. Ver modelos y nos de lote afectados en el anexo adjunto a la nota de aviso de la empresa.
Spain / AEMPS · ESP · Jan 27, 2025
Key facts
| Title | Lima endodóntica rotativa/recíproca de un solo uso EdgeFile X7, EdgeGlidePath, EdgeOne Fire, EdgeOne Fire GlidePath, EdgeTaper y EdgeTaper Platinum. Ver modelos y nos de lote afectados en el anexo adjunto a la nota de aviso de la empresa. |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Lima endodóntica rotativa/recíproca de un solo uso EdgeFile X7, EdgeGlidePath, EdgeOne Fire, EdgeOne Fire GlidePath, EdgeTaper y EdgeTaper Platinum. Ver modelos y nos de lote afectados en el anexo adjunto a la nota de aviso de la empresa. |
| Manufacturer | US Endodontics, LLC., Estados Unidos. |
| Models | 2022-02-11, SETS231HT, 012822346, 00810047640073, SEOFMED31, 423-722-5626, 111121037, 012822303, 2026-02-17, 00810047641599, SX7400629RF, 37604 and 383 more |
| Event type | Safety Notice |
| Date | Jan 27, 2025 |
At a glance
- No Recall
- Yes Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1