EF1 recallZ-2513-2025 · Medshape, INC. · initiated Jun 2, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medshape, INC. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
On 6/2/2025, recall notice were emailed to consignees who were asked to do the following: 1) Review your stock for the products and lot numbers for the items to be returned. 2) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3) Complete acknowledgement and response form and return via email to [email protected] If you have any questions, contact firm at [email protected]
Recall details
- Recall number
- Z-2513-2025
- Status
- Open, Classified
- Initiated by the company
- Jun 2, 2025
- Posted by the FDA
- Sep 3, 2025
- Recalling firm
- Medshape, INC.
- Quantity
- 849
- Product code
- KTT
- FDA submissions
- K151580
- 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.
Product description
Medshape Universal Joints, REF: DNE-9000-UJ
Code information (models, lots, serial numbers)
UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EF1 DNE-9000-UJMedshape, Inc. · Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1 recall3 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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