BEUDAMED
    FDA Recall Open, Classified

    JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

    Recall: Z-0477-2025 · Initiated October 21, 2024

    Recall

    Recall Number
    Z-0477-2025
    Event Number
    95597
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KDD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    October 21, 2024
    Posted
    November 15, 2024
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

    Reason

    Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.

    Action

    Pending

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.

    Quantity

    691 (US); 2,045 (OUS)