Tyber Medical: Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number:
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Tyber Medical
- Product
- 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
- Reason / hazard
- The supplier manufactured anatomical left plates with an incorrect thread orientation.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the state of PA.
- Recall initiated
- 2025-12-19
- Code info
- Model No: 02.426.681S; UDI-DI: 00196449020508; Lot Number: 291294;
- Product quantity
- 100 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bethlehem
- State
- PA
- Country
- United States
- Event id
- 98214
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