The FDA has posted 6 enforcement recalls of endosseous dental implant accessories devices since 2025, none of them Class I (most serious). Most recent report: Feb 18, 2026.
The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown.
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).…
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling).…
Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
The devices are missing the laser marked depth markings.
Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Accessories, Implant, Dental, Endosseous”). Informational only — verify against the FDA before acting.