Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2019 - (Recall #: Z-0363-2020)

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:

Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

Product Classification:

Class II

Date Initiated: October 26, 2018

Date Posted: November 20, 2019

Recall Number: Z-0363-2020

Event ID: 83794

Reason for Recall:

packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.

Status: Terminated

Product Quantity: 53 implants

Code Information:

Lot numbers 120197; Exp. 07/16/2023 and 120198; Exp. 07/19/2023

Distribution Pattern:

US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,

Voluntary or Mandated:

Voluntary: Firm initiated