Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS — Class II medical device recall Z-0775-2020
Terminated recall by Medacta Usa Inc, reported 2020-01-15, distributed nationwide. Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that
| Recall number | Z-0775-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Memphis, TN, United States |
| Recall initiated | 2019-11-04 |
| Classified | 2020-01-03 |
| Reported by FDA | 2020-01-15 |
| Terminated | 2021-05-21 |
| Distributed | Nationwide (US) |
| Quantity | 207 units |
| UPC / GTIN / UDI-DI | 07630040712613 |
| Lot numbers | 184523, 184524, 184525, 184526, 184527, 184528, 184529, 184530, 184531, 184532, 184533, 184534, 184535, 184536, 184537, 184538, 184539, 184540, 184541, 184543, 184544, 184545, 184546, 184547, 184548, 184549, 184550, 184552, 184553, 184554, 184555, 1901138, 1901139 |
| Model numbers | 04.01.0023, 184523, 184524, 184525, 184526, 184527, 184528, 184529, 184530, 184531, 184532, 184533, 184534, 184535, 184536, 184537, 184538, 184539, 184540, 184541, 184543, 184544, 184545, 184546, 184547 and 9 more |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0775-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.