BEUDAMED
    FDA Recall Terminated

    4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.

    Recall: Z-2156-2016 · Initiated February 16, 2016

    Recall

    Recall Number
    Z-2156-2016
    Event Number
    74283
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    February 16, 2016
    Posted
    July 11, 2016
    Terminated
    June 1, 2017
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.

    Reason

    Labeling does not match the cleared indications for use in the United States and Canada.

    Action

    DePuy Synthes initiated a Field Safety Notice to remove the affected Technique Guides and marketing literature from the field. Sales Consultants and Synthes Trauma Marketing will receive training on affected technique guides and marketing literature which promoted off label use. All technique guides and literature have been put on hold and removed from DePuy Synthes website. Effectiveness of this field action will be tracked using their training system. They will confirm training when completed as a means to measure effectiveness.

    Distribution

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

    Quantity

    19,497,844 units in total