| | Class 3 Device Recall |  |
| Date Initiated by Firm | November 01, 2003 |
|---|
| Date Posted | March 15, 2005 |
|---|
| Recall Status1 |
Terminated 3 on April 05, 2005 |
| Recall Number | Z-0624-05 |
|---|
| Recall Event ID |
29993 |
| 510(K)Number | K030318 |
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| Product Classification |
Material, Impression - Product Code ELW
|
| Product | Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. |
|---|
| Code Information |
Lots 190429, 190438, 190519, 190521, 190522, 190524, 190535, 190545, 190547, 190554 and 190560. |
| FEI Number |
1821514
|
Recalling Firm/
Manufacturer |
Heraeus Kulzer Inc.
4315 S Lafayette Blvd
South Bend
IN
46614-2517
|
| For Additional Information Contact |
800-431-1785 |
|---|
Manufacturer Reason
for Recall | Packaging defects could result in improper mixing ratios and unusable impressions. |
|---|
FDA Determined
Cause 2 | Other |
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| Action | Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand.. |
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| Quantity in Commerce | 807 bags. |
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| Distribution | Nationwide. |
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| 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 = ELW
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