Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-1226-2023 · Posted 2023-03-06

Recalling FirmPreat Corp
Recall StatusOpen, Classified
Product CodeEMA
Date Initiated2023-02-01
Product Quantity652 units

Reason for Recall

Product is labeled with an incorrect expiration date.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑