VOLT Wrist Treatment System Plates Recalled for Incorrect Thread Orientation

Agency Publication Date: January 20, 2026

Summary

Tyber Medical is recalling 164 units of its VOLT Wrist Treatment System anatomical left plates used in wrist surgeries. The plates were manufactured with incorrect thread orientation, which can prevent surgical screws from locking into place correctly. Healthcare facilities and surgeons should stop using the affected plates immediately and return them to the manufacturer.

Risk

The incorrect thread orientation on these surgical plates may cause screws to be improperly seated or fail to lock. This can lead to device instability, loss of bone alignment after surgery, or the need for a second surgical procedure to replace the plate.

What You Should Do

This recall affects Tyber Medical VOLT Wrist Treatment System 2 Column Distal Radius Plates (Standard Left) in 139mm and 186mm lengths.
Identify affected products by checking for model numbers 02.426.681S (Lot 291294) or 02.426.691S (Lot 291293) on the sterile packaging or device labels.
Stop using the recalled surgical plates immediately and remove them from surgical inventory.
Contact Tyber Medical at their Bethlehem, PA headquarters to arrange for the return of any unused units and to coordinate replacements.
For healthcare providers, if a patient has already been treated with an affected plate, monitor the patient's recovery as part of standard post-operative care and assess the stability of the implant.
Call the FDA at 1-888-463-6332 for more information regarding this medical device recall.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: VOLT Wrist Treatment System 2 Column Distal Radius Plate (139mm)

Variants: 6 Head, 10 Shaft, Standard Left, 139mm

Model / REF:

02.426.681S

Lot Numbers:

291294

UDI:

00196449020508

Recall #: Z-1131-2026; Quantity: 100 units

Product: VOLT Wrist Treatment System 2 Column Distal Radius Plate (186mm)

Variants: 6 Head, 14 Shaft, Standard Left, 186mm

Model / REF:

02.426.691S

Lot Numbers:

291293

UDI:

00196449020522

Recall #: Z-1132-2026; Quantity: 64 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98214

Status: Active

Manufacturer: Tyber Medical

Sold By: Medical device distributors; Hospitals; Surgical centers

Manufactured In: United States

Units Affected: 2 products (100 units; 64 units)

Distributed To: 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 · 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.

Summary

What You Should Do

This recall affects Tyber Medical VOLT Wrist Treatment System 2 Column Distal Radius Plates (Standard Left) in 139mm and 186mm lengths.

Identify affected products by checking for model numbers 02.426.681S (Lot 291294) or 02.426.691S (Lot 291293) on the sterile packaging or device labels.

Stop using the recalled surgical plates immediately and remove them from surgical inventory.

Contact Tyber Medical at their Bethlehem, PA headquarters to arrange for the return of any unused units and to coordinate replacements.

For healthcare providers, if a patient has already been treated with an affected plate, monitor the patient's recovery as part of standard post-operative care and assess the stability of the implant.

Call the FDA at 1-888-463-6332 for more information regarding this medical device recall.

Affected Products

Product: VOLT Wrist Treatment System 2 Column Distal Radius Plate (139mm)

Variants: 6 Head, 10 Shaft, Standard Left, 139mm

Model / REF:

02.426.681S

Lot Numbers:

291294

UDI:

00196449020508

Recall #: Z-1131-2026; Quantity: 100 units

Product: VOLT Wrist Treatment System 2 Column Distal Radius Plate (186mm)

Variants: 6 Head, 14 Shaft, Standard Left, 186mm

Model / REF:

02.426.691S

Lot Numbers:

291293

UDI:

00196449020522

Recall #: Z-1132-2026; Quantity: 64 units