Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase; catalog number 66009582.
FDA device recall Z-0627-05 · posted 2005-03-15 · Terminated
Recall details
- Recalling firm
- Heraeus Kulzer Inc.
- Reason for recall
- Packaging defects could result in improper mixing ratios and unusable impressions.
- Action taken
- Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand..
- Root cause
- Other
- Status
- Terminated
- Product code
- ELW
- Quantity affected
- 608 bags.
- Distribution
- Nationwide.
- Date initiated
- 2003-11-01
- Date posted
- 2005-03-15
- Date terminated
- 2005-04-05
- Location
- South Bend, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| P2 POLYETHER (K030318) | Heraeus Kulzer, Inc. | 2003-04-03 |