BEUDAMED
    FDA Enforcement Class II Terminated

    3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

    Recall: Z-1710-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1710-2016
    Event ID
    73945
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    April 18, 2016
    Classification Date
    May 23, 2016
    Termination Date
    February 2, 2017
    Address
    1301 Goshen Pkwy, N/A, West Chester, PA, 19380-5986, United States

    Description

    3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).

    Reason

    The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.

    Code Info

    Catalog ID 03.010.100S Lot # 5525872, 6153368, 6530901, 5548707, 6197315, 6581051 5575918, 6199232, 6676406, 5603463, 6231850, 6721724 5649117, 6256560, 6734876, 5668880, 6305842, 6808463 5724639, 6319050, 6831468, 5742276, 6320150, 6997294 5807341, 6343980, 7039877, 6012770, 6401819, 7052565 6045597, 6448707, 7081479, 6057914, 6472100, 7378832 6108342, 6501856, 7410311, 6142443, 6503351, 7466207 7554670, 7620971, 7675571, 7711694, 7801251, 7918026 9815103, 9828932, 9905850, 9939769, H033348

    Distribution

    US Nationwide distribution in the states of: AE, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI

    Quantity

    1274 units