Z-0579-05

PepGen P-15 Putty (0.5cc)

Name: Z-0579-05 PepGen P-15 Putty (0.5cc)
Creator: Dentsply Friadent Ceramed
Published: 2005-02-17
License: https://open.fda.gov/license/

Dentsply Friadent Ceramed / initiated 2005-02-17 / Terminated / root cause: labeling and UDI

FDA source

Dentsply Friadent Ceramed began a recall of PepGen P-15 Putty (0.5cc) on 2005-02-17. The reason FDA records is "PepGen P-15 Putty kit was labeled with the incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0579-05
Status: Terminated
Initiated: 2005-02-17
Posted: 2005-03-09
Terminated: 2005-04-22
Recalling firm: Dentsply Friadent Ceramed
Product: PepGen P-15 Putty (0.5cc)
Product code: NPZ Bone Grafting Material, Dental, With Biologic Component
Reason for recall: PepGen P-15 Putty kit was labeled with the incorrect expiration date.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Customers were sent notification letters dated 02/17/05.
Quantity in commerce: 250 kits
Distribution: Domestic distribution: Nationwide. Foreign distribution: Canada, British Columbia. No military or VA facilites.
Product codes and lots: Article Number: 99U200-005 Lot Number: 04P1017A

Product code NPZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)