FDAApril 10, 2024device
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to incorrect milled titanium abutment being packaged and labeled.
What to do
FDA enforcement status: Ongoing
Brands named
preat
UPCs
008420921594772415889006767
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 90006622025-06-25
- FDAPreat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only2025-06-24
- FDABiomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.2025-04-02
- FDAMultiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-co...2024-06-25
- FDAPreat Nobel Active/Conical-compatible RP Titanium Blank, REF 90009672024-02-09
- FDAPreat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental2023-07-18
- FDAPreat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental2023-07-18
- FDAPreat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental2023-07-18
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