BioHorizons Implant Systems Inc: Medical Device Recall in 2014 - (Recall #: Z-1058-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental

Product Classification:

Class II

Date Initiated: December 10, 2013
Date Posted: February 26, 2014
Recall Number: Z-1058-2014
Event ID: 67090
Reason for Recall:

The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length.

Status: Terminated
Product Quantity: 119 units
Code Information:

Lot Number 1302762, Exp 31 MAY 2018

Distribution Pattern:

Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated