BEUDAMED
    FDA Recall Terminated

    Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.

    Recall: Z-2733-2020 · Initiated June 24, 2020

    Recall

    Recall Number
    Z-2733-2020
    Event Number
    86021
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 24, 2020
    Terminated
    February 16, 2021
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    Description

    Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.

    Reason

    Screws provided in packaging are 5mm shorter than intended

    Action

    Arthrex initiated recall on 06/24/2020. The notification states the following: 1 . Immediately discontinue use, sale, and distribution of the product. 2. Direct Customers (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 3. Arthrex Subsidiaries (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 4. Arthrex Subsidiaries (APAC): a. Please contact Arthrex Product Surveillance at 866-267-9138 or [email protected]. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or [email protected].

    Distribution

    International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands

    Quantity

    28 units