| Date Initiated by Firm | November 17, 2006 |
|---|
| Date Posted | December 01, 2006 |
|---|
| Recall Status1 |
Terminated 3 on April 30, 2007 |
| Recall Number | Z-0232-2007 |
|---|
| Recall Event ID |
36844 |
| 510(K)Number | K032750 |
|---|
| Product Classification |
Dental Implant - Product Code DZE
|
| Product | XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125, Friadent GmbH. (dental implant) |
|---|
| Code Information |
Model # 26-0125 |
| FEI Number |
1721411
|
Recalling Firm/
Manufacturer |
Dentsply Friadent Ceramed
12860 W Cedar Dr Ste 101
Lakewood CO 80228-1965
|
| For Additional Information Contact | Kevin Walls
720-963-4730 |
|---|
Manufacturer Reason
for Recall | Sterility of dental implants may be compromised due to cracks in packaging/caps on vials. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by letter on 11/17/2006 and asked to return all non-implanted product. |
|---|
| Quantity in Commerce | 1680 units |
|---|
| Distribution | Worldwide-USA and one Canadian consignee. |
|---|
| 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
|
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