BEUDAMED
    FDA Recall Terminated

    PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument

    Recall: Z-1696-2015 · Initiated April 30, 2015

    Recall

    Recall Number
    Z-1696-2015
    Event Number
    71250
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 30, 2015
    Posted
    May 29, 2015
    Terminated
    March 15, 2016
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument

    Reason

    Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.

    Action

    On 4/30/2015, URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications dated April 30, 2015 were sent to the affected distributors, hospital Risk Managers, and surgeons via courier; all distributors were also notified via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.

    Distribution

    Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.

    Quantity

    1,689