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U.S. Department of Health and Human Services

Class 2 Device Recall straumann

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 Class 2 Device Recall straumannsee related information
Date Initiated by FirmOctober 27, 2014
Date PostedJanuary 15, 2015
Recall Status1 Terminated 3 on April 10, 2015
Recall NumberZ-0981-2015
Recall Event ID 69767
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
ProductDrill 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
FEI Number 1000121052
Recalling Firm/
Manufacturer		 Straumann USA, LLC
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information ContactBernard M. McDonald
978-747-2514
Manufacturer Reason
for Recall		Drill set may contain incorrect drill.
FDA Determined
Cause 2		Process control
ActionStraumann 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 Commerce362 pieces
DistributionNationwide 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 CycleTPLC 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.
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