Atlantis IO Flo-S Kits A04B and A04S
Brand(s)
Last updated
Summary
Product
Atlantis IO Flo-S Kits A04B and A04S
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Atlantis Io Flo-S Kits A04b And A04s | 68020033 | 10488578 |
| Atlantis Io Flo-S Kits A04b And A04s | 68020033 | 10544044 |
| Atlantis Io Flo-S Kits A04b And A04s | 68020034 | 10556741 |
| Atlantis Io Flo-S Kits A04b And A04s | 68020034 | 10515863 |
| Atlantis Io Flo-S Kits A04b And A04s | 68020034 | 10505543 |
| Atlantis Io Flo-S Kits A04b And A04s | 68020034 | 10512084 |
Issue
Due to a defect in the thread area of an affected IO FLO-S, the device will not be able to be completely engaged and seated with an abutment as intended resulting in an unintended gap between the IO FLO-S and the abutment.
Recall start date: July 23, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Dental
Companies
| Dentsply Implants Manufacturing Gmbh |
| Rodenbacher Chaussee 4, Hanau, Germany, 63457 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77813
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