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Class 2 Device Recall straumann |
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Date Initiated by Firm |
October 27, 2014 |
Date Posted |
January 15, 2015 |
Recall Status1 |
Terminated 3 on April 10, 2015 |
Recall Number |
Z-0981-2015 |
Recall Event ID |
69767 |
Product Classification |
Accessories, implant, dental, endosseous - Product Code NDP
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Product |
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set. |
Code Information |
Lot Numbers: GY037, HA443, HE874, HL216 |
Recalling Firm/ Manufacturer |
Straumann USA, LLC 60 Minuteman Rd Andover MA 01810-1008
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For Additional Information Contact |
Bernard M. McDonald 978-747-2514
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Manufacturer Reason for Recall |
Drill set may contain incorrect drill.
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FDA Determined Cause 2 |
Process control |
Action |
Straumann sent a Field Safety Corrective Action by letter dated October 29, 2014 which was delivered via United Parcel Service. The letter identified the product the problem and the action needed to be taken by the customer.
Customers are asked to examine their inventory and return the product. In addition, customers are asked to complete a Customer Confirmation Form and return it to Straumann via fax to (978)747-0023. |
Quantity in Commerce |
362 pieces |
Distribution |
Nationwide in the following states: AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA and WV. Worldwide in the following countries by Institut Straumann AG distribution network: Austria, Australia, Canada, Germany, Spain, Finland, France, United Kingdom, Netherlands, Belgium, Switzerland, Ireland, Italy. |
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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