Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2019 - (Recall #: Z-0018-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 8, 2018

Date Posted: October 9, 2019

Recall Number: Z-0018-2020

Event ID: 83518

Reason for Recall:

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

Status: Terminated

Product Quantity: 22 vials

Code Information:

Lot number 110350

Distribution Pattern:

Worldwide distribution - US Nationwide including the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated