BioHorizons Implant Systems Inc: Medical Device Recall in 2015 - (Recall #: Z-0391-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 30, 2015

Date Posted: December 16, 2015

Recall Number: Z-0391-2016

Event ID: 72598

Reason for Recall:

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

Status: Terminated

Product Quantity: 32 units

Code Information:

Lot 1404442

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated