Z-0626-05

Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584

Name: Z-0626-05 Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584
Creator: Heraeus Kulzer Inc.
Published: 2003-11-01
License: https://open.fda.gov/license/

Kulzer GmbH / initiated 2003-11-01 / Terminated / root cause: packaging

FDA source

Heraeus Kulzer Inc. began a recall of Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584 on 2003-11-01. The reason FDA records is "Packaging defects could result in improper mixing ratios and unusable impressions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0626-05
Status: Terminated
Initiated: 2003-11-01
Posted: 2005-03-15
Terminated: 2005-04-05
Recalling firm: Kulzer GmbH
Product: Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360); catalog number 66009584.
Product code: ELW Material, Impression
Reason for recall: Packaging defects could result in improper mixing ratios and unusable impressions.
Root cause tag: packaging
FDA root cause: Other
Action: Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand..
Quantity in commerce: 74 bags.
Distribution: Nationwide.
Product codes and lots: Lot 190416.

Product code ELW

K030318Class IIP2 PolyetherHeraeus Kulzer, Inc. / cleared 2003-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)