BEUDAMED
    FDA Recall Terminated

    PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended for uncemented use only.

    Recall: Z-0312-2018 · Initiated June 29, 2017

    Recall

    Recall Number
    Z-0312-2018
    Event Number
    78758
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 29, 2017
    Terminated
    March 7, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended for uncemented use only.

    Reason

    Device was distributed with the etching missing from the product.

    Action

    The firm, Zimmer Biomet, sent an, "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated 6/28/2017 via email and FedEx on approximately 06/29/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were Instructed to ensure appropriate personnel are notified, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to:[email protected] or fax to: 574-372-4265, return all affected products, and provide the names of any locations where product was further distributed to. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected].

    Distribution

    Distributed domestically to MI, MN, ND.

    Quantity

    15 units