Z-1226-2023Class III

PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental...

Name: Z-1226-2023 PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental...
Creator: Preat Corp
Published: 2023-02-01
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2023-02-01 / Open, Classified / root cause: manufacturing process

FDA source

Preat Corp began a recall of PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue on 2023-02-01. FDA classified it as Class III and gives the reason as "Product is labeled with an incorrect expiration date". 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-1226-2023
Classification: Class III
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-06
Recalling firm: PREAT Corporation
Product: PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Product code: EMA Cement, Dental
Reason for recall: Product is labeled with an incorrect expiration date.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm issued letters dated 1/30/2023 on 2/1/2023 via certified mail. The reason for recall was explained and the customer/user was instructed to discard or return the product to the recalling firm. A Medical Device Recall Return Response form was enclosed for the customer to acknowledge they have read and understand the recall instructions. If the product was implanted, they are to provide specific implant dates, the quantities implanted, and available tracking information. They are to indicate they have identified and notified their customers who were shipped the product and if they want the recalling firm to conduct the subrecall, they were to attach a list of customers.
Quantity in commerce: 652 units
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. There was also government distribution. The country of Canada.
Product codes and lots: Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1226-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1226-2023	Class III	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-06

Product code EMA

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)