Implant Direct Sybron Manufacturing LLC FDA Recalls

4 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop lengClass IIMay 1, 2025The Drill stop kit contains incorrect components.	The Drill stop kit contains incorrect components.	Class IIDevices	May 1, 2025
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROWClass IIMay 2, 2023Non-engaging abutments were distributed without FDA clearanc	Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet be	Class IIDevices	May 2, 2023
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,Class IISep 23, 2021Packaged dental implant contains a different size then the s	Packaged dental implant contains a different size then the size declared on the labeling.	Class IIDevices	Sep 23, 2021
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,Class IISep 23, 2021Packaged dental implant contains a different size then the s	Packaged dental implant contains a different size then the size declared on the labeling.	Class IIDevices	Sep 23, 2021