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U.S. Department of Health and Human Services

Class 2 Device Recall RBT, Internal Implant, LaserLok, 5.0 x 15mm, 5.7 Platform

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  Class 2 Device Recall RBT, Internal Implant, LaserLok, 5.0 x 15mm, 5.7 Platform see related information
Date Initiated by Firm October 30, 2015
Date Posted December 07, 2015
Recall Status1 Terminated 3 on February 04, 2016
Recall Number Z-0391-2016
Recall Event ID 72598
510(K)Number K073268  
Product Classification Implant, endosseous, root-form - Product Code DZE
Product RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R),
Dental Implant
Code Information Lot 1404442
Recalling Firm/
BioHorizons Implant Systems Inc
2300 Riverchase Ctr
Hoover AL 35244-2808
For Additional Information Contact Winston Greer
Manufacturer Reason
for Recall
An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging.
FDA Determined
Cause 2
Employee error
Action 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 lpbr5015@biohorizons.com. 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.
Quantity in Commerce 32 units
Distribution Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = BIOHORIZONS IMPLANT SYSTEMS, INC.