BEUDAMED
    FDA Recall Terminated

    Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.

    Recall: Z-1348-2009 · Initiated February 10, 2009

    Recall

    Recall Number
    Z-1348-2009
    Event Number
    51781
    Firm
    Synthes Spine
    FEI Number
    3005180112
    Product Code
    ODP
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 10, 2009
    Posted
    June 10, 2009
    Terminated
    October 5, 2009
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.

    Reason

    Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.

    Action

    All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.

    Distribution

    Distributed Nationwide and Canada.

    Quantity

    1766 units