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U.S. Department of Health and Human Services

Class 3 Device Recall MicroMiniplant

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  Class 3 Device Recall MicroMiniplant see related information
Date Initiated by Firm April 25, 2007
Date Posted May 16, 2007
Recall Status1 Terminated 3 on November 18, 2008
Recall Number Z-0811-2007
Recall Event ID 37865
510(K)Number K934126  
Product Classification Dental implant component - Product Code DZE
Product Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.
Code Information lot Numbers: 593025-5, 593027-5, 598408-5, 593028-5, 599866-5 and 593029-5.
Recalling Firm/
Biomet 3i
4555 Riverside Dr
Palm Beach Gardens FL 33410-4200
Manufacturer Reason
for Recall
The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
FDA Determined
Cause 2
Action Each consignee was notified on 4/25/2007 by telephone using a prepared script. A follow letter was sent by fax. Each consignee was instructed to check their respective inventory for the affected product and to return a response card and any affected product to the firm.
Quantity in Commerce 362 units
Distribution Distributed worldwide, including USA, Spain and the Netherlands.
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 = IMPLANT INNOVATIONS, INC.