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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 Straumann see related information
Date Initiated by Firm November 23, 2016
Create Date January 06, 2017
Recall Status1 Terminated 3 on August 29, 2019
Recall Number Z-0958-2017
Recall Event ID 75983
Product Classification Accessories, implant, dental, endosseous - Product Code NDP
Product Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant accessory
Article Number: 044.255
Dental implants drill accessory is intended to prepare osteotomy site for surgical dental implant placement. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Code Information Lot Number: LV455
Recalling Firm/
Manufacturer		 Straumann Manufacturing, Inc.
60 Minuteman Rd
Andover MA 01810-1008
For Additional Information Contact
800-448-8168
Manufacturer Reason
for Recall		 Drills cannot be inserted into handpiece due to tolerance specification not met
FDA Determined
Cause 2		 Under Investigation by firm
Action Straumann sent an Urgent Field Safety Notice to all affected customers via UPS on November 23, 2016 for next day delivery. Customers were requested to check inventory for the listed article and lot numbers and return all unused, packaged parts. Replacement drills will be sent upon receipt. Complete the Confirmation Form and fax the form to the number listed on the form. For questions regarding this recall call 800-448-8168.
Quantity in Commerce 120 units
Distribution Nationwide Distribution
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.
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