BioHorizons Implant Systems product recalled over labeling errors

Recall date

October 30, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

BioHorizons Implant Systems Inc recalls RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Im…

Recall number

Z-0391-2016

FDA classification

Class II

Brand / firm

BioHorizons Implant Systems Inc

Sold / distributed

Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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