Skip to content

RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform… recallZ-0391-2016 · BioHorizons Implant Systems Inc · initiated Oct 30, 2015

Class II Terminated All recalls posted in December 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from BioHorizons Implant Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Employee error

What the company is doing

BioHorizons sent an Urgent Medical Device Field Correcton letter dated Friday, October 30, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete the enclosed Customer Reply Form and fax to 205-484-2195 or scan to PDF and e-mail to [email protected]. The sole international consignee was notified Monday, 02 November 2015. Customers with questions were instructed to contact the Customer Care Department at 888-246-8338. For questionsn regarding this recall call 205-986-1205.

Recall details

Recall number
Z-0391-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 30, 2015
Posted by the FDA
Dec 7, 2015
Recalling firm
BioHorizons Implant Systems Inc
Quantity
32 units
Product code
DZE
FDA submissions
K073268
Distribution
Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.

Product description

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

Code information (models, lots, serial numbers)

Lot 1404442

Other devices under the same FDA submission

16 devices cleared under K073268 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page