BEUDAMED
    FDA Recall Terminated

    Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.

    Recall: Z-0104-2012 · Initiated September 23, 2011

    Recall

    Recall Number
    Z-0104-2012
    Event Number
    60004
    Firm
    Synthes USA (HQ), Inc.
    FEI Number
    3005180112
    Product Code
    ODP
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    September 23, 2011
    Posted
    October 21, 2011
    Terminated
    December 18, 2014
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.

    Reason

    LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK-CR is utilized as a cervical interbody spacer. PEEK-CR is not currently indicated for use as a cervical interbody spacer.

    Action

    Synthes (USA) sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated September 23, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review the updated supplemental labeling page included with the letter and replace/attach the technique guide page in any Zero-P technique guide that customers may have. The Verification Section of the letter is to be completed and returned to Synthes via fax at 610-251-9005. For questions regarding this notice call 1-800-620-7025 ext. 5403.

    Distribution

    USA (nationwide) including Puerto Rico, Washington, DC and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.