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Wright Medical Technology, Inc. Recall 89461

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

Wright Medical Technology, Inc. Recall 89461 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0679-2022
Event ID89461
Event DescriptionThe 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
Product TypeDevices
DistributionInternational distribution in the countries of Japan and the United Kingdom.
Quantity12 units
Recall ReasonProduct was labelled with the incorrect manufacturing and distribution dates.
Device Classification20220309
Device Code InfoModel No. DCS2825126; Lot No. 11012187061566009
Center Classification Date20220225
Recall Initiation Date20220209
Recalling FirmWright Medical Technology, Inc.
Initial Notification E-Mail
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