FDA Medical devices recall ·
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is… recall
- Recall number
- Z-2172-2025
- Date
- (initiated May 1, 2025)
- Company / brand
- Implant Direct Sybron Manufacturing LLC
3050 E Hillcrest Dr, Westlake Village, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 45 Kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
The Drill stop kit contains incorrect components.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # 15006511/UDI: (10)841307125310
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.
States: Alabama Florida Louisiana Maryland New Jersey Nevada New York Ohio Oklahoma Tennessee Texas Utah Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2172-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.