BEUDAMED
    FDA Recall Terminated

    Zimmer Reconstruction System Tenaculum 3.5 mm Screw Tines, Item # 00-1179-026-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    Recall: Z-0498-2011 · Initiated February 16, 2010

    Recall

    Recall Number
    Z-0498-2011
    Event Number
    55119
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HWN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 16, 2010
    Posted
    December 1, 2010
    Terminated
    October 5, 2011
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Reconstruction System Tenaculum 3.5 mm Screw Tines, Item # 00-1179-026-00, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

    Reason

    The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.

    Action

    Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall. Locate all instruments and quarantine them immediately. Count all affected product in their territory and record the data on the Inventory Return Certification Form included with the letter. Fax a copy of the completed Inventory Return Form to: Zimmer, Inc. at (574) 372-4265. Return the recalled product along with the original completed Inventory Return Certification Form to: Zimmer Distribution Center Attn: Product Service 1777 West Center Street Warsaw, IN 46580 For questions customers were instructed to contact their Zimmer Sales Representative. For questions regarding this recall call 1 - (800) 613-6131.

    Distribution

    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,