Reported Jan 15, 2020 · Terminated

Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage:…

Medacta USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medacta Usa Inc · 3973 Delp St · Memphis, TN · 38118-6110

Is this the product you have?

  • Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055
  • all sizes - Product UsageThe Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement
Lot codes and dates
  • GTIN 07630040712613 REF # Lot

    242 of 242 codes

    • 04.01.23
    • 184523
    • 04.01.23
    • 184523
    • 04.01.23
    • 184523
    • 04.01.23
    • 184523
    • 04.01.23
    • 184523
    • 04.01.23
    • 184523
    • 04.01.24
    • 184524
    • 04.01.24
    • 184524
    • 04.01.24
    • 184524
    • 04.01.25
    • 184525
    • 04.01.25
    • 184525
    • 04.01.25
    • 184525
    • 04.01.26
    • 184526
    • 04.01.26
    • 184526
    • 04.01.26
    • 184526
    • 04.01.27
    • 184527
    • 04.01.27
    • 184527
    • 04.01.27
    • 184527
    • 04.01.27
    • 1901138
    • 04.01.27
    • 1901138
    • 04.01.27
    • 1901138
    • 04.01.27
    • 1901138
    • 04.01.28
    • 184528
    • 04.01.28
    • 184528
    • 04.01.28
    • 1901139
    • 04.01.29
    • 184529
    • 04.01.29
    • 184529
    • 04.01.29
    • 184529
    • 04.01.29
    • 184529
    • 04.01.29
    • 184529
Amount recalled
207 units

Where it was sold

Why it was recalled

Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 21, 2021 · Data as of Sep 19, 5:25 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.