Class II — Potential Health Hazard

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

Implant Direct Recalled by Implant Direct Sybron Manufacturing, LLC Due to packaging error; An internal QA inspection revealed that...

Date: October 26, 2018
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

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

Quantity: 53 implants

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 17 states: AK, AZ, AR, CA, CO, FL, ID, IL, KS, MN, NV, NY, NC, OH, TX, UT, VA

Affected (17 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