CLASS II ONGOING Device recall · Reported 28 Jan 2026 · FDA Enforcement Report
VOLT" Wrist Treatment System 2.4/2.7 2Column Dist Radius recalled
Tyber Medical is recalling VOLT" Wrist Treatment System 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std, distributed nationwide in the US. The recall was initiated on 19 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1131-2026
- FDA event ID
- 98214
- Recalling firm
- Tyber Medical, Bethlehem, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Dec 2025
- FDA classified
- 20 Jan 2026
- Reported
- 28 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Dec 2025 | Recall initiated by company | |
| 20 Jan 2026 | Classified by FDA | +32 days |
| 28 Jan 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Product as listed by the FDA
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
Where it was distributed
US Nationwide distribution in the state of PA.
Questions about this recall
Why was it recalled?
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Which lots are affected?
Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;
Where was it sold?
US Nationwide distribution in the state of PA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 98214This product is part of a recall event; the main page for the event is VOLT" Wrist Treatment System 2.4/2.7 2Column Dist Radius recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | VOLT" Wrist Treatment System 2.4/2.7 2Column Dist Radius recalled | Tyber Medical | Other | Nationwide |
More recalls from Tyber Medical
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | VOLT" Wrist Treatment System 2.4/2.7 2Column Dist Radius recalled | Tyber Medical | Other | Nationwide |
| Device | CLASS II | A.L.P.S. mvX-P: Anatomic Lat Fib Plate 12H LT- Anatomic recalled | Tyber Medical | Other | Nationwide |
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| Device | CLASS II | A.L.P.S. mvX- Anatomic Lat Fib Plate 10H RT- Anatomic recalled | Tyber Medical | Other | Nationwide |
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