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

FDA Device Recall #Z-1226-2023 — Class III — February 1, 2023

Recall Summary

Recall Number Z-1226-2023
Classification Class III — Low risk
Date Initiated February 1, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Preat Corp
Location Santa Maria, CA
Product Type Devices
Quantity 652 units

Product Description

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

Reason for Recall

Product is labeled with an incorrect expiration date.

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.

Lot / Code Information

Product #0102000 - Lot #21V0089; UDI 00842092127308. Product #0102000-3 - Lots 21V0089 and 194397; UDI 00842092155660.

Other Recalls from Preat Corp

Recall # Classification Product Date
Z-2514-2025 Class II NobelBiocare Tri-Lobe-compatible WP X 6.0mm Eng... Jun 25, 2025
Z-2107-2025 Class II Preat, Astra EV-compatible 4.2mm Digital Analog... Jun 24, 2025
Z-1987-2025 Class II Biomet 3i Certain-compatible 4.1 mm Milled Ti A... Apr 2, 2025
Z-2687-2024 Class II Multiple Digital Analog Products labeled as: N... Jun 25, 2024
Z-2318-2024 Class II 9006767 Astra EV 4.8mm Milled Titanium Abutment... Apr 10, 2024

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.