BEUDAMED
    FDA Recall Open, Classified

    OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T

    Recall: Z-1821-2022 · Initiated August 29, 2022

    Recall

    Recall Number
    Z-1821-2022
    Event Number
    90775
    Firm
    Ossur Americas
    FEI Number
    1000519909
    Product Code
    ISW
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 29, 2022
    Posted
    September 28, 2022
    Address
    27051 Towne Centre Dr, Foothill Ranch, CA, 92610-2804

    Description

    OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T

    Reason

    Battery may dislodge from the Power Knee

    Action

    On 08/29/2022, The firm sent via email an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that reports have been received of units where the battery dislodged from the Power Knee units, causing loss of power to the device. This may cause an increase risk for stumbles or falls, potentially leading to an injury. Customer are being instructed to implement a correction to retrofit a security tab to their units. The retrofit kit will be provided with clear instructions for attaching the security tab to the device. In addition, customer are asked to: 1. Pass this notice to those who need to be aware within their organization or to any organization where Power Knee devices have been transferred. 2. Reconcile Ossur s records with their own to ensure all devices are accounted. 3. Once all users have been identified and the retrofit kits have been received, customers will need to schedule each individual to come into their clinic to complete the retrofit process. 4. Sign the acknowledgment form confirming receipt of this notice and that the retrofit process has been completed for all affected devices. Ossur is here to support customers through the process. Contact customer service for further information and assistance. Tel: 1-800-233-6263.

    Distribution

    U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA and WI.

    Quantity

    190 devices