| 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/
Manufacturer |
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 |
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
|
|
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.
|
