Recall
FDAHealthMay 1, 2025

Implant Direct Sybron Manufacturing LLC — 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/remova

⚠️ The Drill stop kit contains incorrect components.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 1, 2025

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.

What's affected?

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.
Lot code
15006511/UDI:

Additional details

Lot # 15006511/UDI: (10)841307125310

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 45 Kits.

View original FDA notice →

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