BEUDAMED
    FDA Recall Terminated

    PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy

    Recall: Z-1383-2017 · Initiated January 31, 2017

    Recall

    Recall Number
    Z-1383-2017
    Event Number
    76487
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 31, 2017
    Posted
    February 27, 2017
    Terminated
    December 1, 2017
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy

    Reason

    These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut.

    Action

    DePuy Synthes mailed an Urgent Notice to customers affected by the issue on 02/13/2017. The reason for the recall was explained, risks associated with the issue were identified, and actions to be taken were addressed. Customers were asked to complete the enclosed Verification form and mail it back to obtain a Return Authorization Number for the product's return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant. For questions regarding this recall call 800-479-6329.

    Distribution

    US distribution to TX and LA

    Quantity

    2 units