medical Class II Updated 2019-10-09

Implant Direct Sybron Manufacturing, LLC recalls ImplantDirect Legacy 3 Implant, REF 855216, SBM implant asse

Recalled Product

ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.


Hazard / Issue

Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot number 110350
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →