Device product
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
Z-0956-2013
Product summary
- Event
- Event 64194
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4
- Official record key
device-enforcement:Z-0956-2013
Official wording
Reason: It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).
Code information: Lot number 7965181
Distribution pattern: Distributed in the states of IN, OH, PA, and TX.
Derived failure modes
-
Unknown
It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).