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Class 2 Device Recall Tapered HD Upgrade Set, REF TSKHDUS |
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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
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Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product |
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only,
Product Usage Usage: Surgical instruments used in preparation for dental implant placement
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Code Information |
Lot Number 1501968 |
Recalling Firm/ Manufacturer |
BioHorizons Implant Systems Inc 2300 Riverchase Ctr Hoover AL 35244-2808
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For Additional Information Contact |
Winston Greer 205-986-1205
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = DZE and Original Applicant = BIOHORIZONS IMPLANT SYSTEMS, INC.
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