Class IIOngoingZ-2172-2025
Implant Direct Sybron Manufacturing LLC recalls The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store
The Drill stop kit contains incorrect components.
Implant Direct Sybron…CAAug 6, 2025
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–3 of 3 recalls
The Drill stop kit contains incorrect components.
The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the change in size was insufficient.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.