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 Legacy 4 Implant Recalled by Implant Direct Sybron Manufacturing, LLC Due to Mislabeling

Date: November 15, 2016
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 Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.

Quantity: 18 units

Why Was This Recalled?

The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.

Where Was This Sold?

This product was distributed to 10 states: FL, GA, MD, MI, NY, NC, OR, TX, UT, VA

Affected (10 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