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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 June 06, 2005
Date Posted July 07, 2005
Recall Status1 Terminated 3 on November 03, 2005
Recall Number Z-0975-05
Recall Event ID 32354
510(K)Number K020096  
Product Classification Implant, Endosseous, Root-Form - Product Code DZE
Product RN synOcta Meso Abutment, crown margin 8.0mm, Ti
Article: 048.560
Code Information Lot Number: 1007
Recalling Firm/
Straumann Manufacturing Inc
60 Minuteman Rd
Andover MA 01810
For Additional Information Contact Linda Jalbert
978-742-2500 Ext. 2506
Manufacturer Reason
for Recall
Basal screw is too short to adequately hold the dental abutment in the implant
FDA Determined
Cause 2
Action Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device.
Quantity in Commerce 23
Distribution AZ, CA, DE, FL, NY, OH, OK, TX
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.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = INSTITUT STRAUMANN AG