FDA Device recall Z-2513-2025
Medshape Universal Joints, REF: DNE-9000-UJ
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of Medshape Universal Joints, REF: DNE-9000-UJ by Medshape, citing bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2513-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-02 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medshape |
| Distribution | US |
Product
Medshape Universal Joints, REF: DNE-9000-UJ
Reason
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
Identifiers
| code_info | UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2513-2025%22
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