Class II — Medshape, INC.
| Recalling firm | MedShape, Incorporated |
|---|---|
| Registered facility | MEDSHAPE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Medshape Universal Joints, REF: DNE-9000-UJ |
| Quantity | 849 |
| Distribution | US Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, PA. |
| Initiated | 2025-06-02 |
| Classified | 2025-09-03 |
| Recall number | Z-2513-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medshape, INC. (Z-2513-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97064/
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