The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop leng
Summary
The FDA issued a Class II for The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to by Implant Direct Sybron Manufacturing LLC. Reason: The Drill stop kit contains incorrect components..
Details
Source
Device Recall
External ID
Z-2172-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
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.
Lot/Code Info: Lot # 15006511/UDI: (10)841307125310
Quantity Affected: 45 Kits
Reason for Recall
The Drill stop kit contains incorrect components.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-01
Company
Westlake Village, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Implant Direct Sybron Manufacturing LLC has 7 FDA actions in our database, including 4 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Implant Direct Sybron Manufacturing LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Implant Direct Sybron Manufacturing LLC have FDA actions?
Implant Direct Sybron Manufacturing LLC has 7 FDA actions in our database, including 4 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2172-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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