Recall Z-2172-2025— Implant Direct Sybron Manufacturing LLC

Name: FDA recall Z-2172-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-01

Class II · Ongoing

Class II FDA medical device recall by Implant Direct Sybron Manufacturing LLC, initiated 2025-05-01. It names one FDA 510(k) clearance: K200858. Product: 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: The Drill stop kit contains incorrect components..

Recalling firm: Implant Direct Sybron Manufacturing LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-05-01
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K200858 — Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC·cleared 2020-08-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.