The FDA has posted 5 enforcement recalls of root-form endosseous implant devices since 2025, none of them Class I (most serious). Most recent report: Oct 8, 2025.
Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and pe…
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
It is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead.
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm;…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Implant, Endosseous, Root-Form”). Informational only — verify against the FDA before acting.