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U.S. Department of Health and Human Services

Class 3 Device Recall Impression Set, dental

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  Class 3 Device Recall Impression Set, dental see related information
Date Initiated by Firm June 15, 2010
Date Posted August 06, 2010
Recall Status1 Terminated 3 on September 22, 2011
Recall Number Z-2177-2010
Recall Event ID 56049
Product Classification Endosseous Dental Implant Accessories. - Product Code NDP
Product Straumann Impression set for WN solid abutment H 4.00mm POM/ AI. Ref : 040.380 Kit Y4021.

Intended to aid in the fabrication of dental prosthetics, and be used as a accessory with endosseous dental implants.
Code Information Lot # Y4021
Recalling Firm/
Manufacturer		 Straumann Manufacturing Inc.
60 Minuteman Rd
Andover MA 01810
For Additional Information Contact same
978-747-2514
Manufacturer Reason
for Recall		 The label on the tubular packaging for the Straumann Impression set f. WN solid abutment has the incorrect description of RN solid abutment instead of a WN.
FDA Determined
Cause 2		 Labeling mix-ups
Action Field Safety Notice, dated June 15, 2010, issued to consignees states that the 040.380 Impression set f. WN solid abutment Lot Y4021 which you purchased is incorrectly labeled Impression set f. RN solid abutment. Customers were asked to return the affected products and completed Customer Confirmation Form for replacements. Questions should be directed towards Bernard McDonald at 978-747-2514.
Quantity in Commerce 163
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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