FDA-Device2013-09-04Class II
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.
Synthes USA HQ, Inc.
Hazard
The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with "R" for right plate when they should be etched with "L" for left plate.
Sold states
USA Nationwide Distribution in the states of FL, GA, NC, OH, KY, NJ, ID, IN, and MN.
Affected count
11
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2087-2013Don't want to check this manually?
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