Recall Z-1226-2023 ยท EMA Cement, Dental
Preat Corp
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
| Date | Mar 6, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | Product is labeled with an incorrect expiration date. |
| 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.