BEUDAMED
    FDA Recall Open, Classified

    LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

    Recall: Z-1674-2023 · Initiated April 25, 2023

    Recall

    Recall Number
    Z-1674-2023
    Event Number
    92294
    Firm
    Linkbio Corp.
    FEI Number
    3006721341
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 25, 2023
    Posted
    June 1, 2023
    Address
    101 Round Hill Dr, Ste 7, Rockaway, NJ, 07866-1214

    Description

    LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

    Reason

    Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

    Action

    LinkBio Corp. issued Urgent Medical Device Recall on 4/25/23 via email to Distributors. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801. Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

    Distribution

    US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX

    Quantity

    11 units