BEUDAMED
    FDA Enforcement Class II Terminated

    U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads porous coated, ¿54mm U2 Acetabular cup, Ti beads porous coated, ¿56mm U2 Acetabular cup, Ti beads porous coated, ¿58mm U2 Acetabular cup, Ti beads porous coated, ¿60mm U2 Acetabular cup, Ti beads porous coated, ¿62mm U2 Acetabular cup liner assembly, 10¿hooded,44mm U2 Acetabular cup liner assembly, 10¿hooded,46mm U2 Acetabular cup liner assembly, 10¿hooded,48mm U2 Acetabular cup liner assembly, 10¿hooded,50mm U2 Acetabular cup liner assembly, 10¿hooded,52mm U2 Acetabular cup liner assembly, 10¿hooded,54mm U2 Acetabular cup liner assembly, 10¿hooded,56mm U2 Acetabular cup liner assembly, 10¿hooded,58mm U2 Acetabular cup liner assembly, 10¿hooded,60mm U2 Acetabular cup liner assembly, 10¿hooded,62mm Variety of hip and knee implants and instruments, multiple uses.

    Recall: Z-1381-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1381-2013
    Event ID
    64588
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthopedic Alliance LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    February 20, 2013
    Classification Date
    May 24, 2013
    Termination Date
    March 26, 2014
    Address
    26157 Jefferson Ave, N/A, Murrieta, CA, 92562-9561, United States

    Description

    U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads porous coated, ¿54mm U2 Acetabular cup, Ti beads porous coated, ¿56mm U2 Acetabular cup, Ti beads porous coated, ¿58mm U2 Acetabular cup, Ti beads porous coated, ¿60mm U2 Acetabular cup, Ti beads porous coated, ¿62mm U2 Acetabular cup liner assembly, 10¿hooded,44mm U2 Acetabular cup liner assembly, 10¿hooded,46mm U2 Acetabular cup liner assembly, 10¿hooded,48mm U2 Acetabular cup liner assembly, 10¿hooded,50mm U2 Acetabular cup liner assembly, 10¿hooded,52mm U2 Acetabular cup liner assembly, 10¿hooded,54mm U2 Acetabular cup liner assembly, 10¿hooded,56mm U2 Acetabular cup liner assembly, 10¿hooded,58mm U2 Acetabular cup liner assembly, 10¿hooded,60mm U2 Acetabular cup liner assembly, 10¿hooded,62mm Variety of hip and knee implants and instruments, multiple uses.

    Reason

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

    Code Info

    Item No. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662

    Distribution

    Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

    Quantity

    30 units