Implant Direct Sybron Manufacturing LLC: Medical Device Recall in 2025 - (Recall #: Z-2172-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 1, 2025

Date Posted: August 6, 2025

Recall Number: Z-2172-2025

Event ID: 96778

Reason for Recall:

The Drill stop kit contains incorrect components.

Status: Ongoing

Product Quantity: 45 Kits

Code Information:

Lot # 15006511/UDI: (10)841307125310

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.

Voluntary or Mandated:

Voluntary: Firm initiated