Device product
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
Z-1132-2026
Product summary
- Firm
- Tyber Medical
- Event
- Event 98214
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 64 units
- Official record key
device-enforcement:Z-1132-2026
Official wording
Reason: The supplier manufactured anatomical left plates with an incorrect thread orientation.
Code information: Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293
Distribution pattern: US Nationwide distribution in the state of PA.
Derived failure modes
-
Unknown
The supplier manufactured anatomical left plates with an incorrect thread orientation.