Medshape Universal Joints, REF: DNE-9000-UJ
Reported: September 10, 2025 Initiated: June 2, 2025 #Z-2513-2025
Product Description
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.
Details
- Recalling Firm
- Medshape, INC.
- Units Affected
- 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.
- Location
- Atlanta, GA
Frequently Asked Questions
What product was recalled? ▼
Medshape Universal Joints, REF: DNE-9000-UJ. Recalled by Medshape, INC.. Units affected: 849.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2513-2025.
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