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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:191658

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 recall number

Z-0679-2022

Evidence summary

Product code
HRS
Recall status
Terminated
Event initiated
February 09, 2022
Root cause
Packaging process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0679-2022

Field note

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