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
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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/ Manufacturer |
Biomet 3i 4555 Riverside Dr Palm Beach Gardens FL 33410-4200
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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 | Other |
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 |
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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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510(K) Database | 510(K)s with Product Code = DZE
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