BEUDAMED
    FDA Recall Terminated

    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument

    Recall: Z-1312-2016 · Initiated February 16, 2016

    Recall

    Recall Number
    Z-1312-2016
    Event Number
    73600
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    FZX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 16, 2016
    Terminated
    December 7, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument

    Reason

    DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi

    Action

    DePuy Synthes sent an Urgent Notice to inform customers that they were initiating a voluntary recall of lot numbers: 1776197, 5706588, 1782340 and 1868678 of the Interlocking Bolt which are part of the Synthes 4.5mm LCP Proximal Tibia Plate System. Customers were asked to review their inventory for the affected lots, call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verifcation Section (page 3 of the letter) identifying that the affected product has been located and return it to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. A copy of the Verification Section of the letter was to be faxed to 866-737-4701 or emailed to: [email protected].

    Distribution

    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.

    Quantity

    42 plate systems