FDA-Device2016-06-22Class II
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Synthes (USA) Products LLC
Hazard
Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.
Sold states
Distributed to one customer: Colorado
Affected count
6 units
Manufactured in
1301 Goshen Pkwy, West Chester, PA, United States
Products
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1949-2016Don't want to check this manually?
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