Z-2172-2025Class II

The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify...

Name: Z-2172-2025 The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify...
Creator: Implant Direct Sybron Manufacturing LLC
Published: 2025-05-01
License: https://open.fda.gov/license/

Implant Direct Sybron Manufacturing LLC / initiated 2025-05-01 / Open, Classified

FDA source

Implant Direct Sybron Manufacturing LLC began a recall of 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... on 2025-05-01. FDA classified it as Class II and gives the reason as "The Drill stop kit contains incorrect components". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2172-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-01
Posted: 2025-07-25
Recalling firm: Implant Direct Sybron Manufacturing LLC
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.
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Reason for recall: The Drill stop kit contains incorrect components.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 45 Kits
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 codes and lots: Lot # 15006511/UDI: (10)841307125310

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2172-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2172-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-25

Product code KCT

K200858Class IIMini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC / cleared 2020-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)