Recall Z-0775-2020 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Medacta Usa Inc
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.
| Date | Nov 4, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| 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. |
| Quantity | 207 units |
| Distribution | US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170910 | Medacta Anatomic Shoulder Prosthesis Medacta International S.A., Aug 16, 2017 |