Dentsply IH, Inc. has recalled 882 units of Atlantis IO FLO-S Kits because a defect in the thread area prevents the device from fully connecting with dental implants. The threads only allow for approximately 2 rotations instead of the required 5, creating a 1mm difference in engagement depth. This kit is used for taking digital impressions to help restore chewing function in patients who are missing teeth.
The improper threading prevents full engagement with the implant or replica, which can lead to inaccurate digital models. This inaccuracy could result in ill-fitting dental prosthetics or surgical suprastructures that do not function correctly in the patient's mouth.
Intended for enabling digital impression taking on implant or abutment levels.
Intended for enabling digital impression taking on implant or abutment levels.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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