BEUDAMED
    FDA Recall Terminated

    Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.

    Recall: Z-0393-2014 · Initiated October 15, 2013

    Recall

    Recall Number
    Z-0393-2014
    Event Number
    66551
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 15, 2013
    Posted
    November 26, 2013
    Terminated
    August 31, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.

    Reason

    One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.

    Action

    SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product was located. Customers were also asked to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers should also return the Verification Form if no affected product was found in their inventory. Return all documents to Synthes by fax: 888-679-4875 or Scan/email: [email protected] Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

    Distribution

    Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.

    Quantity

    approximately 44