Z-0679-2022 Class II Terminated

Recalled by Wright Medical Technology, Inc. — Memphis, TN

Recall Details

Product Type
Devices
Report Date
March 9, 2022
Initiation Date
February 9, 2022
Termination Date
January 25, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 units

Product Description

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 Pattern

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

Code Information

Model No. DCS2825126; Lot No. 11012187061566009