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U.S. Department of Health and Human Services

Class 3 Device Recall NOBIL GRIP

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  Class 3 Device Recall NOBIL GRIP see related information
Date Initiated by Firm February 01, 2023
Date Posted March 06, 2023
Recall Status1 Open3, Classified
Recall Number Z-1226-2023
Recall Event ID 91614
Product Classification Cement, dental - Product Code EMA
Product PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
Code Information Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.
Recalling Firm/
Manufacturer		 Preat Corp
2625 Skyway Dr Ste B
Santa Maria CA 93455-1405
For Additional Information Contact Nichole Fetterman
800-232-7732
Manufacturer Reason
for Recall		 Product is labeled with an incorrect expiration date.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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