The Drill Stop Kit is the version of the Mini Sterilizable… recallZ-2172-2025 · Implant Direct Sybron Manufacturing LLC · initiated May 1, 2025
Class II Open, Classified All recalls posted in July 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Implant Direct Sybron Manufacturing LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Drill stop kit contains incorrect components.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2172-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- May 1, 2025
- Posted by the FDA
- Jul 25, 2025
- Recalling firm
- Implant Direct Sybron Manufacturing LLC
- Quantity
- 45 Kits
- Product code
- KCT
- FDA submissions
- K200858
- Distribution
- 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.
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.
Code information (models, lots, serial numbers)
Lot # 15006511/UDI: (10)841307125310
Other devices under the same FDA submission
2 devices cleared under K200858 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Drill Stop Kit - Long CDSKLImplant Direct Sybron Manufacturing LLC · Sterilization Wrap Containers, Trays, Cassettes & Other Accessories1 report
- Drill Stop Kit - Long Empty DSKLImplant Direct Sybron Manufacturing LLC · Sterilization Wrap Containers, Trays, Cassettes & Other Accessories1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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