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EndoPilot² expansion DownPack²
Schlumbohm GmbH & Co. KG · Model v01 · UDI-DI 04260482991173
1
510(k) clearances
71
Adverse events
3
Recalls
143
Facilities
Description
EndoPilot DownPack expansion set consist of: D-Pack² handpiece, with LED-indicator, Heating-tip size: fine, EQV and a D-Pack/Backfill holder left
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-27 | Ormco/Sybronendo | Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU). |
| 2013-01-17 | Ormco/Sybronendo | A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Uni |
| 2013-01-17 | Ormco/Sybronendo | A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Uni |
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