BEUDAMED
    FDA Enforcement Class II Ongoing

    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771

    Recall: Z-2702-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2702-2020
    Event ID
    85984
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 5, 2020
    Initiation Date
    June 24, 2020
    Classification Date
    July 24, 2020
    Address
    150 Minuteman Rd, N/A, Andover, MA, 01810-1031, United States

    Description

    Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures. REF/ Catalog Number : 014771

    Reason

    The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

    Code Info

    Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408

    Distribution

    Worldwide distribution - US Nationwide distribution including in the state of CO and the countries of AT, BE, CH, CL, DE, DK, ES, FR, GB, IT. Expanded 8/28/20 recall: 2nd Field Action: AU, CH, DE, FR, GB, IT, NL, PL, PT, & ZA

    Quantity

    137 Lot 2042492; 130 Lot 2049408