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U.S. Department of Health and Human Services

Class 3 Device Recall SPI EASY Abutment

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  Class 3 Device Recall SPI EASY Abutment see related information
Date Initiated by Firm April 19, 2007
Date Posted July 24, 2007
Recall Status1 Terminated 3 on May 12, 2008
Recall Number Z-1086-2007
Recall Event ID 38267
510(K)Number K023645  
Product Classification Endosseous dental implant abutment. - Product Code DZE
Product SPI EASY Abutment. Endosseous dental implant abutment.
Code Information #4_03_700 Batch 8007 REF: 1.03.700 LOT: 5121
Recalling Firm/
Thommen Medical, AG
Hauptstrasse, 87
Waldenburg Switzerland
For Additional Information Contact Mr. David Gentile
Manufacturer Reason
for Recall
The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.
FDA Determined
Cause 2
Action Letter 5/14/2007. Customers are requested to check their current inventory for the recall product. If found they are to return the product for replacement. If they have implanted the product they are to check patient x-rays for the defect. If defects are found they are to do a restoration.
Quantity in Commerce 84
Distribution Nationwide.
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 = THOMMEN MEDICAL, AG