Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ImplantDirect Recalled by Implant Direct Sybron Manufacturing, LLC Due to The main vial label lists the incorrect part...

Date: March 3, 2017
Company: Implant Direct Sybron Manufacturing, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Implant Direct Sybron Manufacturing, LLC directly.

Affected Products

ImplantDirect, Dental implants 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.

Quantity: 124 units

Why Was This Recalled?

The main vial label lists the incorrect part number, but the cap label is correct.

Where Was This Sold?

This product was distributed to 16 states: AZ, CA, CO, CT, FL, ID, IL, NV, NJ, NY, NC, PA, TX, UT, VA, WA

Affected (16 states)Not affected

About Implant Direct Sybron Manufacturing, LLC

Implant Direct Sybron Manufacturing, LLC has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report