Z-1272-02

Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020

Name: Z-1272-02 Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
Creator: Den-Tal-Ez Inc,Star Dental Div
Published: 2003-05-16
License: https://open.fda.gov/license/

Dentalez, Inc., Stardental Division / initiated 2003-05-16 / Terminated / root cause: labeling and UDI

FDA source

Den-Tal-Ez Inc,Star Dental Div began a recall of Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020 on 2003-05-16. The reason FDA records is "problems with product label". 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-1272-02
Status: Terminated
Initiated: 2003-05-16
Posted: 2004-07-20
Terminated: 2004-03-19
Recalling firm: Dentalez, Inc., Stardental Division
Product: Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020
Reason for recall: problems with product label
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The recalling firm issued recall letters to the accounts via certified mail on 5/16/03.
Quantity in commerce: 231 units
Distribution: The products were shipped to 6 accounts in PA, IL, UT, MD, and NY. Three accounts are government/military locations.
Product codes and lots: Lot number 765370 - Serial Number XR0007058 Lot number 779057 - Serial Numbers XR0006002 through XR0006017 Lot number 790256 - Serial Numbers XR0006018 through XR0006032 Lot number 793359 - Serial Numbers XR0006033 through XR0006039; XR0006042 through XR0006050 Lot number 802157 - Serial Numbers XR0006056 through XR0006061 Lot number 806758 - Serial Numbers XR0007001 through XR0007006 Lot number 808557 - Serial Numbers XR0007007 through XR0007014; XR0007018 through XR0007019; XR0007021 through XR0007022 Lot number 812560 - Serial Numbers XR0007023 through XR0007034 Lot number 815057 - Serial Numbers XR0007035 through XR0007046 Lot number 819457 - Serial Numbers XR0007053 through XR0007057; XR0007059 through XR0007064; XR0007070 Lot number 828262 - Serial Numbers XR0007071 through XR0007081; XR0008001 through XR0008014 Lot number 843969 - Serial Numbers XR0008015 through XR0008022; XR0008025 through XR0008034; XR0008037 through XR0008038; XR0008058 through XR0008062 Lot number 854056 - Serial Numbers XR0008039 through XR0008046; XR0008048 through XR0008057; XR0008063 through XR0008064 Lot number 858667 - Serial Numbers XR0008065 through XR0008077 Lot number 886858 - Serial Numbers XR0009033 and XR0010041 Lot number 991168 - Serial Number XR0107030 Lot number 1116310 - Serial Numbers XR0108024; XR0107026 through XR0107029; XR0107036 through XR0107065 Lot number 1241582 - Serial Numbers XR0203022 through XR0203023 Lot number SHOW UNIT ¿ Serial Number XR0107066

K021378Class IIPortable Hdx Intraoral X-RayDentalez Group / cleared 2002-06-07

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)