The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize,...

FDA Device Recall #Z-2172-2025 — Class II — May 1, 2025

Recall Summary

Recall Number Z-2172-2025
Classification Class II — Moderate risk
Date Initiated May 1, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Implant Direct Sybron Manufacturing LLC
Location Westlake Village, CA
Product Type Devices
Quantity 45 Kits

Product Description

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short  6-13mm depth, and Long  6-16mm depth), and in several diameters for different diameter drills.

Reason for Recall

The Drill stop kit contains incorrect components.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ, NV, NY, OH, OK, TN, TX, UT, VA and the country of Japan.

Lot / Code Information

Lot # 15006511/UDI: (10)841307125310

Other Recalls from Implant Direct Sybron Manufacturing LLC

Recall # Classification Product Date
Z-2037-2023 Class II LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE;... May 2, 2023
Z-0198-2022 Class II ImplantDirect, REF 834713, Legacy 2 Implant 4.7... Sep 23, 2021
Z-0197-2022 Class II ImplantDirect, REF 834711, Legacy 2 Implant 4.7... Sep 23, 2021
Z-1157-2020 Class II Implant Direct, CE 0086, REF: 855710, Legacy 3 ... Oct 11, 2019
Z-1041-2020 Class II Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD ... Oct 7, 2019

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.