Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Tyber Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Surgical Plate
- Model numbers
- Model No: 02.426.691S, UDI-DI: 00196449020522, Lot Number: 291293
- Sold at
- Unknown
- 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 a medical device used in surgical procedures for treating wrist fractures. Surgeons and healthcare professionals purchase this product for its precision in stabilizing wrist structures during healing.
Why This Is Dangerous
The incorrect thread orientation in the anatomical left plates can lead to improper installation, which may jeopardize the success of surgical procedures and patient recovery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this device face potential surgical complications, underscoring the urgent need for immediate action to ensure safety.
Practical Guidance
How to identify if yours is affected
- Locate the model number 02.426.691S on your device.
- Check for the lot number 291293 for confirmation of the recall.
- Contact your healthcare provider if unsure about your device.
Where to find product info
Serial numbers and model information can typically be found on the product packaging or the device itself, often on a label attached to the plate.
What timeline to expect
Expect a response from Tyber Medical regarding refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Document all communication attempts with Tyber Medical.
- Reach out again via email or phone if you do not receive a timely response.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- Always verify product recalls through official channels before use.
- Check for FDA approval and quality certifications when purchasing medical devices.
- Consult healthcare professionals about product safety before surgical procedures.
Documentation advice
Keep records of your purchase, including receipts and any correspondence regarding the recall for your records.
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Product Details
The recalled product is the VOLT Wrist Treatment System, model number 02.426.691S. It features a 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm. This product was distributed nationwide in the United States, specifically in Pennsylvania.
Key Facts
- Model No: 02.426.691S
- Distributed in Pennsylvania
- Incorrect thread orientation
- Class II recall, high hazard level
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Safety Guide
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