Z-2421-2020Class II

HYGENIC Winged Fiesta Kit, Model no. H02778 -

Name: Z-2421-2020 HYGENIC Winged Fiesta Kit, Model no. H02778 -
Creator: Coltene Whaledent Inc
Published: 2020-06-03
License: https://open.fda.gov/license/

Coltene /Whaledent AG / initiated 2020-06-03 / Open, Classified / root cause: manufacturing process

FDA source

Coltene Whaledent Inc began a recall of HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the... on 2020-06-03. FDA classified it as Class II and gives the reason as "Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2421-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-06-03
Posted: 2020-06-23
Recalling firm: Coltene /Whaledent AG
Product: HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.
Product code: EJG Forceps, Rubber Dam Clamp
Reason for recall: Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified affected customers on June 3, 2020 by sending out Urgent Medical Device Recall letters. Customers were informed that multiple batches of the product do not meet specification. If you received one of the affected batches, please check the laser marked batch number on the forceps. If the laser marked batch number directly on the forceps matches one of the listed numbers, you should return the forceps. The recalling firm will replace your product at no cost. If you have already used the product, please inform the firm. If you should have additional questions, please contact: Tricia Cregger, Ph.D., RAC, CBA Director of Regulatory / R&D Coltene/Whaledent, Inc. 235 Ascot Parkway Cuyahoga Falls, OH 44223 USA [email protected] Phone: 330-916-8817 Fax: 330-916-7093
Quantity in commerce: 7,206 forceps
Distribution: Pending
Product codes and lots: Batch numbers: J38382 J28715 J24868 J28716 J33647 J43944 J50980 J47108 J57802 J57061 J67133 J74174 J68563 J72691 If a distributor or end user received one of the batches listed above, they need to look at the batch number laser marked on the forceps themselves. If the forceps has any of the following batch numbers laser marked on them and the forceps do not fit with the dental dam clamps, the forceps should be returned to Coltene. Laser marked batch number: 1903 1904 1906 1907 1909 1910 1911 1915 1920 1921 1923 1927 1928 1930 1934 1940

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2421-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2419-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-01	2020-06-23
Z-2420-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-01	2020-06-23
Z-2421-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-01	2020-06-23
Z-2422-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-01	2020-06-23

Product code EJG

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)