Heraeus Kulzer Inc. Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585.
Brand
Heraeus Kulzer Inc.
Lot Codes / Batch Numbers
Lots 190429, 190438, 190519, 190521, 190522, 190524, 190535, 190545, 190547, 190554 and 190560.
Products Sold
Lots 190429, 190438, 190519, 190521, 190522, 190524, 190535, 190545, 190547, 190554 and 190560.
Heraeus Kulzer Inc. is recalling Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. due to Packaging defects could result in improper mixing ratios and unusable impressions.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Packaging defects could result in improper mixing ratios and unusable impressions.
Recommended Action
Per FDA guidance
Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand..
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026