BEUDAMED
    FDA Recall Open, Classified

    Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013

    Recall: Z-0583-2024 · Initiated November 21, 2023

    Recall

    Recall Number
    Z-0583-2024
    Event Number
    93507
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    November 21, 2023
    Posted
    January 18, 2024
    Address
    2320 Nw 66th Ct, Gainesville, FL, 32653-1630

    Description

    Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013

    Reason

    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

    Action

    Exactech issued an URGENT MEDICAL DEVICE RECALL notice to its direct consignees on 11/21/2023 via email. The notice explained the issue, clinical impact, and requested the removal and return of all affected products. 11/22/2023, the firm initiated the recall OUS also by email.

    Distribution

    US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK