| Date Initiated by Firm | November 01, 2003 |
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| Date Posted | March 15, 2005 |
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| Recall Status1 |
Terminated 3 on April 05, 2005 |
| Recall Number | Z-0625-05 |
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| Recall Event ID |
29993 |
| 510(K)Number | K030318 |
|---|
| Product Classification |
Material, Impression - Product Code ELW
|
| Product | Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583. |
|---|
| Code Information |
Lots 195402, 195404, 195405, 195411, 195412 and 195420. |
Recalling Firm/
Manufacturer |
Heraeus Kulzer Inc.
4315 S Lafayette Blvd
South Bend IN 46614-2517
|
| For Additional Information Contact |
800-431-1785 |
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Manufacturer Reason
for Recall | Packaging defects could result in improper mixing ratios and unusable impressions. |
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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 | 1183 bags. |
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| Distribution | Nationwide. |
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| 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.
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| 510(K) Database | 510(K)s with Product Code = ELW
|
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