BEUDAMED
    FDA Recall Terminated

    Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.

    Recall: Z-0792-06 · Initiated March 30, 2006

    Recall

    Recall Number
    Z-0792-06
    Event Number
    35109
    Firm
    Synthes (USA)
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2006
    Posted
    April 26, 2006
    Terminated
    September 20, 2006
    Address
    1302 Wrights Lane East, West Chester, PA, 19380

    Description

    Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.

    Reason

    Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.

    Action

    Synthes Craniofacial Sales consultants were notified and instructed to immediately notify their accounts concerning this recall. Synthes contacted the customer accounts via phone 3/31/06 through 4/3/06 and subsequently via Certified Mail on 4/3/06.

    Distribution

    Nationwide and Canada. Distribution to 1 Military/Government account - Tripler Army Medical Center, Honolulu, HI; 1 foreign account - Synthes Canada; and geographical distribution within the United States to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, AND WV.

    Quantity

    3511