FDA Medical Device Recalls (openFDA)
Heraeus Kulzer Inc.: Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585.
- Recall number
- Z-0624-05
- Recalling firm
- Heraeus Kulzer Inc.
- Product
- Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585.
- Status
- Terminated
- Initiated
- 2003-11-01
- Posted
- 2005-03-15
- Terminated
- 2005-04-05
- Reason
- Packaging defects could result in improper mixing ratios and unusable impressions.
- Root cause
- Other
- Action
- Customers were notified via undated letter on or about November 1, 2003 and instructed to return product on hand..
- Quantity
- 807 bags.
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lots 190429, 190438, 190519, 190521, 190522, 190524, 190535, 190545, 190547, 190554 and 190560.
- 510(k) numbers
- ["K030318"]
- PMA numbers
- not on file
- Product code
- ELW
- Firm FEI
- 1821514
- Firm city
- South Bend
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28