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U.S. Department of Health and Human Services

Class 2 Device Recall Tapered HD Upgrade Set, REF TSKHDUS

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  Class 2 Device Recall Tapered HD Upgrade Set, REF TSKHDUS see related information
Date Initiated by Firm April 16, 2015
Date Posted May 12, 2015
Recall Status1 Terminated 3 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/
BioHorizons Implant Systems Inc
2300 Riverchase Ctr
Hoover AL 35244-2808
For Additional Information Contact Winston Greer
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 2
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 and Original Applicant = BIOHORIZONS IMPLANT SYSTEMS, INC.