Medshape, INC.: Device Recall
Recall #Z-2513-2025 · 06/02/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2513-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Medshape, INC.
- Status
- Ongoing
- Date Initiated
- 06/02/2025
- Location
- Atlanta, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 849
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.
Product Description
Medshape Universal Joints, REF: DNE-9000-UJ
Distribution Pattern
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.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.