Medshape Universal Joints — Class II medical device recall Z-2513-2025
Ongoing recall by Medshape, INC., reported 2025-09-10, distributed nationwide. Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the u
| Recall number | Z-2513-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medshape, INC., Atlanta, GA, United States |
| Recall initiated | 2025-06-02 |
| Classified | 2025-09-03 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 849 |
| UPC / GTIN / UDI-DI | 00810028397101 |
| Lot numbers | 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921 |
| Model numbers | DNE-9000-UJ |
Product
Medshape Universal Joints, REF: DNE-9000-UJ
Reason for recall
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.
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-2513-2025. 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.