BEUDAMED
    FDA Enforcement Class II 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 · Reported January 10, 2018

    Enforcement

    Recall Number
    Z-0312-2018
    Event ID
    78758
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 10, 2018
    Initiation Date
    June 29, 2017
    Classification Date
    January 4, 2018
    Termination Date
    March 7, 2018
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    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.

    Code Info

    Model No. 11-116062, Lot No. 374670, UDI No. (01) 0 0880304 59316 9 (17) 270513 (10) 374670

    Distribution

    Distributed domestically to MI, MN, ND.

    Quantity

    15 units