FDA Device recall Z-0603-2020
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and…
- FDA Device
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and… by Miami Device Solutions, citing right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0603-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-15 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Miami Device Solutions |
| Distribution | US |
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
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Identifiers
| code_info | Lot number PM00208 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0603-2020%22
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