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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medshape Universal Joints Recalled for Pin Dislodgement and Instability Risk

Agency Publication Date: September 3, 2025
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Summary

Medshape, INC. has recalled 849 Medshape Universal Joints (REF: DNE-9000-UJ) because a pin in the bone external fixation system can become dislodged. This defect can lead to instability in the frame used to stabilize bones, which may cause a delay in surgery or require a follow-up revision procedure. This recall affects various production lots sold to hospitals, surgical centers, and medical distributors.

Risk

The pin dislodgement causes the external fixation frame to become unstable. This instability can lead to complications during surgery or necessitate additional corrective surgeries to stabilize the bone properly.

What You Should Do

  1. This recall affects Medshape Universal Joints (REF: DNE-9000-UJ) used in bone external fixation systems with UDI-DI 00810028397101.
  2. Identify if your product is affected by checking the lot numbers on the packaging. Affected lot numbers include 001927, 002274, 002301, 002309, 002314, and others. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer, Medshape, INC., or your distributor to arrange for the return, replacement, or correction of the units.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions or concerns regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medshape Universal Joints
Model / REF:
DNE-9000-UJ
Lot Numbers:
001927
002274
002301
002309
002314
002322
002535
009389
090921
32422
5432
5875
61120
90921
UDI:
00810028397101

Recall #: Z-2513-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97064
Status: Active
Manufacturer: Medshape, INC.
Sold By: Hospitals; Surgical Centers; Medical Distributors
Manufactured In: United States
Units Affected: 849
Distributed To: California, Illinois, New Jersey, Texas, Florida, Indiana, Ohio, Wisconsin, Virginia, Massachusetts, South Carolina, Washington, North Carolina, Iowa, Montana, Arizona, Colorado, Nevada, Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.