FDA-Device2022-03-09Class II
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
Wright Medical Technology, Inc.
Hazard
Product was labelled with the incorrect manufacturing and distribution dates.
Sold states
International distribution in the countries of Japan and the United Kingdom.
Affected count
12 units
Manufactured in
1023 Cherry Rd, Memphis, TN, United States
Products
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm screws which intersect each other in pairs. The drill holes of the plates are aligned to assure the screws do not touch. The various plates model numbers differ from each other through among other things different curvatures, material strengths, lengths, number of plate holes and through different grades and bridge widths
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0679-2022Don't want to check this manually?
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