Class II — Potential Health Hazard

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

RBT Recalled by BioHorizons Implant Systems Inc Due to An incorrect label reading 10.5mm and not the...

Date: October 30, 2015
Company: BioHorizons Implant Systems Inc
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 BioHorizons Implant Systems Inc directly.

Affected Products

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant

Quantity: 32 units

Why Was This Recalled?

An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.

Where Was This Sold?

This product was distributed to 10 states: AZ, CA, CO, GA, MD, MI, NY, NC, OH, WA

Affected (10 states)Not affected

About BioHorizons Implant Systems Inc

BioHorizons Implant Systems Inc has 5 total recalls tracked by RecallDetector.

Related Recalls

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