BEUDAMED
    FDA Recall Terminated

    Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O 620004820 TRILOGY ACET SHELL 48MM O 620004822 TRILOGY ACET SHELL 48MM O 620004823 TRILOGY ACET SHELL 48MM O 620005020 TRILOGY ACET SHELL 50MM O 620005021 TRILOGY ACET SHELL 50MM O 620005022 TRILOGY ACET SHELL 50MM O 620005220 TRILOGY ACET SHELL 52MM O 620005221 TRILOGY ACET SHELL 52MM O 620005222 TRILOGY ACET SHELL 52MM O 620005223 TRILOGY ACET SHELL 52MM O 620005420 TRILOGY ACET SHELL 54MM O 620005421 TRILOGY ACET SHELL 54MM O 620005422 TRILOGY ACET SHELL 54MM O 620005423 TRILOGY ACET SHELL 54MM O 620005620 TRILOGY ACET SHELL 56MM O 620005621 TRILOGY ACET SHELL 56MM O 620005622 TRILOGY ACET SHELL 56MM O 620005623 TRILOGY ACET SHELL 56MM O 620005820 TRILOGY ACET SHELL 58MM O 620005821 TRILOGY ACET SHELL 58MM O 620005822 TRILOGY ACET SHELL 58MM O 620005823 TRILOGY ACET SHELL 58MM O 620006020 TRILOGY ACET SHELL 60MM O 620006022 TRILOGY ACET SHELL 60MM O 620006023 TRILOGY ACET SHELL 60MM O 620006021 TRILOGY ACET SHELL 60MM OD SOLID 620006220 TRILOGY ACET SHELL 62MM O 620006221 TRILOGY ACET SHELL 62MM O 620006222 TRILOGY ACET SHELL 62MM O 620006420 TRILOGY ACET SHELL 64MM O 620006422 TRILOGY ACET SHELL 64MM O 620006620 TRILOGY ACET SHELL 66MM O For use in total hip arthroplasty

    Recall: Z-1161-2016 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-1161-2016
    Event Number
    72900
    FEI Number
    1000132037
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 11, 2016
    Posted
    March 12, 2016
    Terminated
    April 13, 2017
    Address
    Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715

    Description

    Product 63 consists of all product under product code: LPH and same usage: Item no: 620004020 TRILOGY ACET SHELL 40MM O 620004220 TRILOGY ACET SHELL 42MM O 620004420 TRILOGY ACET SHELL 44MM O 620004620 TRILOGY ACET SHELL 46MM O 620004621 TRILOGY ACET SHELL 46MM O 620004820 TRILOGY ACET SHELL 48MM O 620004822 TRILOGY ACET SHELL 48MM O 620004823 TRILOGY ACET SHELL 48MM O 620005020 TRILOGY ACET SHELL 50MM O 620005021 TRILOGY ACET SHELL 50MM O 620005022 TRILOGY ACET SHELL 50MM O 620005220 TRILOGY ACET SHELL 52MM O 620005221 TRILOGY ACET SHELL 52MM O 620005222 TRILOGY ACET SHELL 52MM O 620005223 TRILOGY ACET SHELL 52MM O 620005420 TRILOGY ACET SHELL 54MM O 620005421 TRILOGY ACET SHELL 54MM O 620005422 TRILOGY ACET SHELL 54MM O 620005423 TRILOGY ACET SHELL 54MM O 620005620 TRILOGY ACET SHELL 56MM O 620005621 TRILOGY ACET SHELL 56MM O 620005622 TRILOGY ACET SHELL 56MM O 620005623 TRILOGY ACET SHELL 56MM O 620005820 TRILOGY ACET SHELL 58MM O 620005821 TRILOGY ACET SHELL 58MM O 620005822 TRILOGY ACET SHELL 58MM O 620005823 TRILOGY ACET SHELL 58MM O 620006020 TRILOGY ACET SHELL 60MM O 620006022 TRILOGY ACET SHELL 60MM O 620006023 TRILOGY ACET SHELL 60MM O 620006021 TRILOGY ACET SHELL 60MM OD SOLID 620006220 TRILOGY ACET SHELL 62MM O 620006221 TRILOGY ACET SHELL 62MM O 620006222 TRILOGY ACET SHELL 62MM O 620006420 TRILOGY ACET SHELL 64MM O 620006422 TRILOGY ACET SHELL 64MM O 620006620 TRILOGY ACET SHELL 66MM O For use in total hip arthroplasty

    Reason

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to [email protected]. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

    Distribution

    US Nationwide Distribution

    Quantity

    2063