BEUDAMED
    FDA Enforcement Class II Terminated

    8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202

    Recall: Z-1635-2020 · Reported April 8, 2020

    Enforcement

    Recall Number
    Z-1635-2020
    Event ID
    84987
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2020
    Initiation Date
    November 4, 2019
    Classification Date
    April 1, 2020
    Termination Date
    April 28, 2021
    Address
    727 N Shepherd Dr Ste 100, N/A, Houston, TX, 77007-1320, United States

    Description

    8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202

    Reason

    The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.

    Code Info

    Part Number: 220-08-003, Lot Number: TSL007202;Expiration Date: 12/25/2023.

    Distribution

    Distributors in 21 states: AR, AZ, CA, FL, GA, IA,IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI.

    Quantity

    117