Safety Alert: Class II: 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.
healthClass IIRecalled on Sep 10, 2025
Medshape Universal Joints, REF: DNE-9000-UJ
🔢 849
Sold At: Medshape, INC.(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 #: FDA-DEVICE-Z-2513-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
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Summary
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 to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Medshape, INC. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.