BEUDAMED
    FDA Enforcement Class II Terminated

    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

    Recall: Z-0196-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0196-2019
    Event ID
    81090
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medacta Usa Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 31, 2018
    Initiation Date
    November 15, 2017
    Classification Date
    October 19, 2018
    Termination Date
    March 29, 2019
    Address
    3973 Delp St, N/A, Memphis, TN, 38118-6110, United States

    Description

    Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery.

    Reason

    Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

    Code Info

    a) REF 01.13.100L, GTIN 07630030803130 b) REF 01.13.101L, GTIN 07630030803154 c) REF 01.13.102L, GTIN 07630030803178 d) REF 01.13.103L, GTIN 07630030803192 e) REF 01.13.104L, GTIN 07630030803215 f) REF 01.13.105L, GTIN 07630030803239 g) REF 01.13.106L, GTIN 07630030803253 h) REF 01.13.107L, GTIN 07630030803277 I) REF 01.13.108L, GTIN 07630030803291 j) REF 01.13.100R, GTIN 07630030803147 k) REF 01.13.101R, GTIN 07630030803161 l) REF 01.13.102R, GTIN 07630030803185 m) REF 01.13.103R, GTIN 07630030803208 n) REF 01.13.104R, GTIN 07630030803222 o) REF 01.13.105R, GTIN 07630030803246 p) REF 01.13.106R, GTIN 07630030803260 q) REF 01.13.107R, GTIN 07630030803284 r) REF 01.13.108R, GTIN 07630030803307 Lots produced with the old version of the packaging, including lot numbers less than 169041.

    Distribution

    NC, ID, Belgium, Switzerland, Spain, Germany, Australia, France, Italy

    Quantity

    837 units