BEUDAMED
    FDA Recall 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 · Initiated November 4, 2019

    Recall

    Recall Number
    Z-1635-2020
    Event Number
    84987
    Firm
    Trilliant Surgical, LLC
    FEI Number
    3007420745
    Product Code
    HTY
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 4, 2019
    Posted
    April 1, 2020
    Terminated
    April 28, 2021
    Address
    727 N Shepherd Dr, Ste 100, Houston, TX, 77007-1320

    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.

    Action

    The recall strategy included sending complete recall communication and response forms as of 11/04/2019 via FedEx (Express Standard Overnight) to all consignees that showed possession / had been sold a device as of 10/30/2019. The recall communication included the following actions to be taken by the distributor/customer: 1. Check inventory stock for the identified device. 2. Open the shipper box* on the end opposite of the label and remove the internal packaging. *Note: Opening the shipper box does not disrupt the sterile barrier. The double sterile barrier is maintained within the internal packaging. 3. Through the transparent internal packaging, verify that the kit contains the appropriate quantity and type of each reamer; (1) Concave Reamer and (1) Convex Reamer. If product in possession IS identified as affected by containing (2) of the same reamer type, quarantine and/or discontinue use of the device and return the affected device(s) to the firm in accordance with the included Return Response (Acknowledgment and Receipt Form). If product in possession IS NOT affected (i.e. there is 1 Concave Reamer and 1 Convex Reamer within the packaging, complete and return the included Return Response (Acknowledgment and Receipt Form). THE INCLUDED RETURN RESPONSE IS REQUIRED EVEN IF AFFECTED PRODUCT IS NOT IDENTIFIED. For questions regarding the communication, the phone number is 800.495.2919.

    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