Health product recall

Atlantis IO Flo-S Kits A04B and A04S

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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