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
04.01.2318452304.01.2318452304.01.2318452304.01.2318452304.01.2318452304.01.2318452304.01.2418452404.01.2418452404.01.2418452404.01.2518452504.01.2518452504.01.2518452504.01.2618452604.01.2618452604.01.2618452604.01.2718452704.01.2718452704.01.2718452704.01.27190113804.01.27190113804.01.27190113804.01.27190113804.01.2818452804.01.2818452804.01.28190113904.01.2918452904.01.2918452904.01.2918452904.01.2918452904.01.29184529
- GTIN 07630040712613 REF # Lot
- 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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