BEUDAMED
    FDA Recall Open, Classified

    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46

    Recall: Z-1508-2023 · Initiated March 21, 2023

    Recall

    Recall Number
    Z-1508-2023
    Event Number
    92088
    Firm
    Linkbio Corp.
    FEI Number
    3006721341
    Product Code
    HSX
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    March 21, 2023
    Posted
    May 4, 2023
    Address
    101 Round Hill Dr, Ste 7, Rockaway, NJ, 07866-1214

    Description

    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46

    Reason

    Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected

    Action

    LinkBio issued Urgent Medical Device Correction letter on March 21, 2023 to US Distributors. Letter states reason for recall, health risk and action to take: Please take note of the amendment / reinforcement of the Surgical Technique and participate in future offering of product training on the updated technique. Two warnings have been added. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to follow the updated surgical technique. Attendance in future product training on the LINK SLED is required for continued use of the system. No action is required for devices which have already been implanted; continue with regular follow-up activities for patients who have received the LINK SLED knee system. All product lots of the above item numbers still within the labeled expiration date are in scope for this device correction. Waldemar Link GmbH & Co. KG is updating the surgical technique to incorporate the new warnings. The company will also be providing product training, through the LinkBio Medical Education team. Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

    Distribution

    NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus

    Quantity

    18 units