BEUDAMED
    FDA Recall Terminated

    Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system.

    Recall: Z-1958-2013 · Initiated April 22, 2013

    Recall

    Recall Number
    Z-1958-2013
    Event Number
    64970
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    FSM
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    April 22, 2013
    Posted
    August 13, 2013
    Terminated
    November 6, 2015
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    Description

    Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system.

    Reason

    Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.

    Action

    On 2/15/2013, SpineFrontier emailed distributors informing them that they needed specific parts returned to work towards completing the conversion of product graphics.

    Distribution

    Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic.

    Quantity

    258 units (30 in distribution at the time of the recall)