Medshape Universal Joints recall
Medshape Universal Joints, REF: DNE-9000-UJ
Why was Medshape Universal Joints 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
- Product
- Medshape Universal Joints, REF: DNE-9000-UJ
- Recalling firm
- Medshape, INC.
- 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.
- Recall date
- September 10, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)