FDA recall Z-0679-2022

Wright Medical Technology, Inc. · Class II · 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

Reason for recall

Product was labelled with the incorrect manufacturing and distribution dates.

Distribution

International distribution in the countries of Japan and the United Kingdom.

Key facts

Status
Terminated
Initiation date
2022-02-09
Report date
2022-03-09
Termination date
2024-01-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0679-2022