Device product
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
Z-0679-2022
Product summary
- Event
- Event 89461
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-0679-2022
Official wording
Reason: Product was labelled with the incorrect manufacturing and distribution dates.
Code information: Model No. DCS2825126; Lot No. 11012187061566009
Distribution pattern: International distribution in the countries of Japan and the United Kingdom.
Derived failure modes
-
Unknown
Product was labelled with the incorrect manufacturing and distribution dates.