Preat Corp is recalling 145 units of Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutments (REF 9001767-F) because of a manufacturing defect. The products were manufactured with a screw seat located too high, which prevents the mating screw from having a long enough engagement into the dental implant. While no injuries or incidents have been reported, dental practices and distributors should stop using these specific components and contact the manufacturer to arrange for their return.
Because the screw seat is positioned incorrectly, the screw that secures the abutment to the implant may not grip enough of the implant's threads. This can lead to the prosthetic restoration becoming loose or failing to stay attached to the patient's dental implant.
Milled abutments used for dental restorations.
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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