Proximal Humerus Plate — Class II medical device recall Z-0603-2020
Terminated recall by Miami Device Solutions, LLC., reported 2019-12-11, distributed nationwide. Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
| Recall number | Z-0603-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Miami Device Solutions, LLC., Miami, FL, United States |
| Recall initiated | 2019-01-15 |
| Classified | 2019-12-05 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| Lot numbers | PM00208 |
| Model numbers | MDS130108R |
Product
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20¿. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.
Reason for recall
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
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-0603-2020. 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.