Implant Direct Sybron Manufacturing, LLC: Medical Device Recall in 2019 - (Recall #: Z-0364-2020)

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, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants

Product Classification:

Class II

Date Initiated: August 9, 2019

Date Posted: November 20, 2019

Recall Number: Z-0364-2020

Event ID: 83763

Reason for Recall:

A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

Status: Terminated

Product Quantity: 23 implants

Code Information:

Lot #135128 Exp: 3/12/20

Distribution Pattern:

U.S.: IN, VA, MD, TX, WA OUS: Japan

Voluntary or Mandated:

Voluntary: Firm initiated