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Open, Classified

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.

FDA Recall Z-2172-2025 · Posted 2025-07-25

Recalling FirmImplant Direct Sybron Manufacturing LLC
Recall StatusOpen, Classified
Product CodeKCT
Date Initiated2025-05-01
Product Quantity45 Kits

Reason for Recall

The Drill stop kit contains incorrect components.

Firm Action

On May 2, 2025, Implant Direct issued a "Urgent: Medical Device Recall" Notification" letter to affected consignees via UPS or Email. Implant Direct ask consignees to take the following actions: 1. Please check your inventory immediately for any affected units and quarantine to ensure the product is not used. 2. PLEASE SHARE THIS NOTICE WITH THOSE WHO NEED TO BE AWARE WITHIN YOUR ORGANIZATION. 3. IMPLANT DIRECT KINDLY REQUESTS YOUR COOPERATION IN COMPLETING AND EMAILING BACK THE ENCLOSED ACKNOWLEDGEMENT FORM IN ORDER TO CONFIRM YOUR RECEIPT OF THIS URGENT MEDICAL DEVICE RECALL LETTER, REGARDLESS OF WHETHER YOU HAVE ANY PRODUCT IN YOUR INVENTORY.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200858Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC · 2020-08-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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