FDA-Device2013-03-27Class II

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.

Synthes USA HQ, Inc.
Hazard

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).

Sold states
Distributed in the states of IN, OH, PA, and TX.
Affected count
4
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0956-2013

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