BEUDAMED
    FDA Recall Terminated

    Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

    Recall: Z-3207-2011 · Initiated March 11, 2011

    Recall

    Recall Number
    Z-3207-2011
    Event Number
    59290
    Firm
    Synthes USA (HQ), Inc.
    FEI Number
    3005180112
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    March 11, 2011
    Posted
    September 15, 2011
    Terminated
    December 18, 2014
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes T1 Matrix Locking Cap of the Synthes Matrix System, Part Number 04.632.000. Intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

    Reason

    Labeling Correction -- The locking cap was not able to be loosened, resulting in the breakage of the screwdriver or the rod to be cut and the assembly to be removed (screw, cap, and rod). This poses a potential risk of significant prolongation of OR time.

    Action

    The firm initiated this action on March 11, 2011 by issuing an Urgent: Medical Device Labeling Correction letter to all consignees. The letter identified the affected product and stated the reason for the correction. It also instructed the consignee to review and attach the supplementary technique page to any MATRIX Spine System Technique Guides that they may have had in their facility. Customers are to complete the Verification Section of the letter and return it to the firm via mail, fax, or e-mail. If customers have questions, they can call 610-719-5063 or their Synthes Spine Sales Consultant.

    Distribution

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