Dentsply recalls Atlantis IO FLO-S Kit (model A04B/68020033) due to thread engagement defect causing improper implant fitting. Affected units may not fully engage with implants, risking inaccurate prosthetic placement.
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
Dentsply is recalling Atlantis IO FLO-S dental kits with model numbers A04B or 68020033 because the thread design fails to fully engage with dental implants. This defect could lead to incorrect prosthetic placement if used in dental procedures.
The kit's threads only engage about 2 rotations instead of the required 5 rotations with dental implants. This small difference in engagement depth (about 1mm) can cause improper prosthetic placement during dental procedures.
Dentists and dental technicians using the Atlantis IO FLO-S dental kit for implant procedures are most at risk. Patients receiving dental work with this kit may experience inaccurate prosthetic placement.
Check for model numbers A04B or 68020033 on the Atlantis IO FLO-S dental kit. The product was sold with lot numbers 10544044 and 10488578.
Verify the model number on the kit is A04B or 68020033.
The threads in the kit only engage about 2 rotations instead of the required 5 rotations with dental implants, which can lead to inaccurate prosthetic placement.
The defect causes a 1mm difference in depth of engagement, potentially resulting in improper prosthetic placement during dental procedures.
The recall record does not specify a remedy, so check with Dentsply for further instructions.
We’ve drafted a message you can send Dentsply to request your refund or repair — edit it as you like.
Subject: Recall Z-2421-2025 — Dentsply Dentsply Hello, I own a Dentsply that is covered by recall Z-2421-2025 from Dentsply. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
