FDA Medical Device Recalls (openFDA)
Dentsply Friadent Ceramed: PepGen P-15 Putty (0.5cc)
- Recall number
- Z-0579-05
- Recalling firm
- Dentsply Friadent Ceramed
- Product
- PepGen P-15 Putty (0.5cc)
- Status
- Terminated
- Initiated
- 2005-02-17
- Posted
- 2005-03-09
- Terminated
- 2005-04-22
- Reason
- PepGen P-15 Putty kit was labeled with the incorrect expiration date.
- Root cause
- Other
- Action
- Customers were sent notification letters dated 02/17/05.
- Quantity
- 250 kits
- Distribution
- Domestic distribution: Nationwide. Foreign distribution: Canada, British Columbia. No military or VA facilites.
- Lot, serial or model codes
- Article Number: 99U200-005 Lot Number: 04P1017A
- 510(k) numbers
- not on file
- PMA numbers
- ["P990033"]
- Product code
- NPZ
- Firm FEI
- 1721411
- Firm city
- Lakewood
- Firm state
- CO
- 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