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.
FDA Recall Z-0775-2020 · Posted None
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Recalling FirmMedacta Usa Inc
Recall StatusTerminated
Product CodeKWS
Date Initiated2019-11-04
Date Terminated2021-05-21
Product Quantity207 units
Reason for Recall
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.
Firm Action
On 11/4/19 all distributors with recalled product were immediately notified of the recall by phone. On 11/5/19, all distributors were further notified of the recall via email and requested to return their product to the Memphis warehouse.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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