Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy + Light; catalog number 66009583.

FDA Recall Z-0625-05 · Posted 2005-03-15

Recalling FirmHeraeus Kulzer Inc.
Recall StatusTerminated
Product CodeELW
Date Initiated2003-11-01
Date Terminated2005-04-05
Product Quantity1183 bags.

Reason for Recall

Packaging defects could result in improper mixing ratios and unusable impressions.

Firm Action

Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand..

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030318P2 POLYETHERHeraeus Kulzer, Inc. · 2003-04-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑