Dentsply recalls Atlantis IO FLO-S kits (model A04S/6802034) 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 kits (model A04S/6802034) because the thread design fails to fully engage with dental implants, leading to improper depth of fit. This could cause inaccurate prosthetic placement and affect chewing function in patients.
The thread area in the kit won't fully engage with dental implants or analogs, only rotating about 2 times instead of the required 5 rotations. This results in a 1mm difference in depth of engagement, potentially causing improper prosthetic placement.
Dentists and dental technicians who use the Atlantis IO FLO-S kits for dental prosthetics are most at risk. Patients with dental implants may experience inaccurate prosthetic placement if the kit is used.
Check for the model number A04S or catalog number 6802034 on the Atlantis IO FLO-S kit. The product was sold with lot numbers 10515863, 10512084, 10505543, and 10556741.
Verify the model number (A04S) or catalog number (6802034) on the Atlantis IO FLO-S kit.
The thread area in the kit won't fully engage with dental implants or analogs, only rotating about 2 times instead of the required 5 rotations. This results in a 1mm difference in depth of engagement, potentially causing improper prosthetic placement.
The recall record does not specify a remedy, so check the product details to confirm if it's affected and contact Dentsply for further guidance.
The recall indicates a risk of improper prosthetic placement, but the hazard is described as low risk as it doesn't cause immediate injury or serious harm in normal use.
We’ve drafted a message you can send Dentsply to request your refund or repair — edit it as you like.
Subject: Recall Z-2422-2025 — Dentsply Dentsply Hello, I own a Dentsply that is covered by recall Z-2422-2025 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.
