Class 2 Device Recall Tapered HD Upgrade Set, REF TSKHDUS

• Date Initiated by Firm: April 16, 2015
• Date Posted: May 12, 2015
• Recall Status: Terminated on August 07, 2015
• Recall Number: Z-1605-2015
• Recall Event ID: 71125
• 510(K)Number: K071638
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• Product: Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
• Code Information: Lot Number 1501968
• Recalling Firm/ Manufacturer: BioHorizons Implant Systems Inc; 2300 Riverchase Ctr; Hoover AL 35244-2808
• For Additional Information Contact: Winston Greer; 205-986-1205
• Manufacturer Reason for Recall: BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
• FDA Determined Cause: Process control
• Action: BioHorizons sent an Urgent Medical Device Field Correction letter on 04/16/2015 to affected customers. Non-responding customers will be notified after 30 days. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Care Department at 888-246-8338.
• Quantity in Commerce: 48 units
• Distribution: US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.
• 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