BEUDAMED
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    Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

    FDA Recall
    Terminated ·Tournier, Inc.·Product code KWS·October 20, 2008

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020