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All product recalls associated with Biomet 3i, LLC.
Total Recalls
12
Past Year
0
Class I (Serious)
0
Most Recent
Aug 2020
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.
Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for use in this product.
Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.
Healing Abutment was not made within required manufacturing specification. The product did not have the relief behind the thread, which does not allow proper seating.