BEUDAMED
    FDA Enforcement Class II Terminated

    All instrumentation associated with the Prelude PF Resurfacing Knee System.

    Recall: Z-1318-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1318-2016
    Event ID
    73489
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    March 9, 2016
    Classification Date
    April 4, 2016
    Termination Date
    May 23, 2017
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    All instrumentation associated with the Prelude PF Resurfacing Knee System.

    Reason

    Inadequate design control.

    Code Info

    All Lots of All Prelude PF instrumentation part numbers. Part Number Description 110004338: No. 1 Femoral Trial, Left 110004248: No. 1 Femoral Trial, Right 110004339: No. 2 Femoral Trial, Left 110004250: No. 2 Femoral Trial, Right 110004344: No. 3 Femoral Trial, Left 110004252: No. 3 Femoral Trial, Right 110004342: No. 4 Femoral Trial, Left 110004254: No. 4 Femoral Trial, Right 110004341: No. 5 Femoral Trial, Left 110004256: No. 5 Femoral Trial, Right 110004337: No. 6 Femoral Trial, Left 110004258: No. 6 Femoral Trial, Right 110004340: No. 6W Femoral Trial, Left 110004260: No. 6W Femoral Trial, Right 110004343: No. 7W Femoral Trial, Left 110004262: No. 7W Femoral Trial, Right 110004345: No. 8W Femoral Trial, Left 110004264: No. 8W Femoral Trial, Right 110004105: No. 1 Drill Guide, Left 110004106: No. 1 Drill Guide, Right 110004107: No. 2 Drill Guide, Left 110004108: No. 2 Drill Guide, Right 110004109: No. 3 Drill Guide, Left 110004110: No. 3 Drill Guide, Right 110004111: No.4 Drill Guide, Left 110004112: No.4 Drill Guide, Right 110004113: No. 5 Drill Guide, Left 110004114: No. 5 Drill Guide, Right 110004115: No. 6 Drill Guide, Left 110004116: No. 6 Drill Guide, Right 110004117: No. 6W Drill Guide, Left 110004118: No. 6W Drill Guide, Right 110004119: No. 7W Drill Guide, Left 110004120: No. 7W Drill Guide, Right 110004121: No. 8W Drill Guide, Left 110004122: No. 8W Drill Guide, Right 010001763: 25MM Reamer 010001768: 31MM Reamer 110004151: 25MM Stop Collar 110004165: 31MM Stop Collar 110007428: Stop Collar Push Button 110004170: 2.1MM Guide Pin 110004169: Trial Remover 110004172: Impactor Handle 110007398: 15 Degree Rasp 597004: Instrument Case 110018820: 25MM Peek Bushing 110018821: 31MM Peek Bushing

    Distribution

    US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.

    Quantity

    576