Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Tyber Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Tyber Medical
- Product type
- Wrist Treatment System
- Model numbers
- Model No: 02.426.681S, UDI-DI: 00196449020508, Lot Number: 291294
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The supplier manufactured anatomical left plates with an incorrect thread orientation.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tyber Medical or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The VOLT Wrist Treatment System is used for treating wrist conditions requiring surgical intervention. It is designed to stabilize the wrist during recovery and is typically used in clinical settings by healthcare professionals.
Why This Is Dangerous
The defect in thread orientation can lead to improper attachment of the plate, potentially resulting in inadequate stabilization during healing and increased risk of complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this device for treatment may face delays in their recovery if they need to return the product and seek alternatives.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device; it should read 02.426.681S.
- Verify the lot number, which is 291294, to confirm if your device is affected.
- If unsure, contact your healthcare provider for assistance.
Where to find product info
Model numbers can typically be found on the packaging or the device itself, often near the serial number.
What timeline to expect
Refund processing typically takes 4-6 weeks after returning the product to Tyber Medical.
If the manufacturer is unresponsive
- Document all communications with Tyber Medical.
- Reach out to your healthcare provider for further assistance.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Ensure any medical device is FDA approved and check for safety certifications.
- Consult with healthcare professionals about alternative devices.
Documentation advice
Keep copies of all correspondence regarding the recall and any receipts for returned products.
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Product Details
The recalled product is identified as the VOLT Wrist Treatment System, model number 02.426.681S. The system consists of a 2 Column Distal Radius Plate with 6 heads and a 10 shaft, designed specifically for the left wrist. The recall involves 100 units distributed nationwide in the U.S., particularly in Pennsylvania.
Key Facts
- Product Model: 02.426.681S
- Recall Date: December 19, 2025
- Quantity Recalled: 100 units
- Distribution: Nationwide in PA
- Hazard: Incorrect thread orientation
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Safety Guide
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