FDA-Device2020-01-15Class II
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The 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.
Medacta Usa Inc
Hazard
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.
Sold states
US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.
Affected count
207 units
Manufactured in
3973 Delp St, N/A, Memphis, TN, United States
Products
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0775-2020Don't want to check this manually?
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