BEUDAMED
    FDA Recall Terminated

    CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

    Recall: Z-0954-2023 · Initiated October 20, 2022

    Recall

    Recall Number
    Z-0954-2023
    Event Number
    91109
    Firm
    CoreLink LLC
    FEI Number
    3006494201
    Product Code
    MAX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 20, 2022
    Posted
    January 12, 2023
    Terminated
    August 20, 2024
    Address
    2072 Fenton Logistics Park, Fenton, MO, 63026-2504

    Description

    CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

    Reason

    Specific lots of FLXfit implants have internal components that may have been manufactured using stainless steel rather than the specified titanium alloy.

    Action

    CoreLink initiated their recall by telephone to the physicians on 10/20/2022. The firm followed with a letter sent by FedEx. The letter explained the problem and the potential risk for health: "Potential Risks to Health: Please be aware that our records indicate your practice may have used one or more of the affected AT3208 devices (as shown in the table above), and that patients implanted with a FLXfit Expandable Interbody Spacer from affected lots should be monitored for: 1. MRI Safety: FLXfit devices, per current labeling, are not approved in the MR environment, and additionally, this labeling does not specify the presence of 17-4 Surgical Grade Stainless Steel. There is a possible risk of patient injury while scanning a patient implanted with FLXfit devices. The additional risk from the presence of steel is believed to be very low as published studies1,2,3, have shown negligible implant heating and no measurable device migration in an MR environment at 3 Tesla with stainless steel implants containing as much as 65% Iron content by weight and 31 times great mass than the affected devices1. 2. Implant Corrosion: There is a remote possibility for implant corrosion over time, which may result in localized pain, swelling, and tenderness, and may weaken the implant. If fusion does not occur, there is an increased potential for implant failure. CoreLink believes this is a remote possibility due in part to the passivation process performed in accordance with ASTM A967 that removes free iron particles on the surface of the affected component and creates a corrosion resistant passive surface layer. 3. Nickel Sensitivity: Patients with nickel sensitivities may experience non-life threatening4,5 allergic reactions to the implant material and implant removal may be necessary to alleviate these effects. We do not anticipate this issue to affect the structural integrity of the implant. The level of Nickel in the component by weight is .9% of the total mass, this is compara

    Distribution

    US Nationwide distribution.

    Quantity

    18 units