BEUDAMED
    FDA Recall Terminated

    Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

    Recall: Z-1028-2022 · Initiated March 30, 2022

    Recall

    Recall Number
    Z-1028-2022
    Event Number
    89983
    FEI Number
    3014833750
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    March 30, 2022
    Posted
    April 29, 2022
    Terminated
    August 28, 2023
    Address
    311 W Corporation St, Inc. restor3d, Durham, NC, 27701-2409

    Description

    Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument

    Reason

    During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

    Action

    An email was sent out to the consignees on 03/31/2022. All customers were instructed to segregate any affected product and contact Restor3d. If all product has already been returned to restor3d, the consignee is to indicate that on the enclosed response form. On 04/19/2022, the firm extended the recall to two additional lots. The recall notification was sent to the consignees via email with a request for all affected product to be returned.

    Distribution

    US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

    Quantity

    9 units