BEUDAMED
    FDA Recall Terminated

    BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.

    Recall: Z-0812-2022 · Initiated February 14, 2022

    Recall

    Recall Number
    Z-0812-2022
    Event Number
    89701
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDR
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 14, 2022
    Terminated
    September 30, 2024
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.

    Reason

    Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.

    Action

    A recall notification was sent via courier 24 Feb 2022 to distributors, surgeons, and hospital risk managers. Customers advised to locate and quarantine product, return to Biomet and identify any further customers receiving product. Recalled product is identified using specific lot and item numbers. Additionally, surgeons and hospital risk managers are to follow any specified patient monitoring instructions and return the Certificate of Acknowledgement to Zimmer Biomet. If you have further questions or concerns, please call customer service at 574-371-3071 or send questions via email to [email protected]

    Distribution

    Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands

    Quantity

    2594