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
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0679-2022 |
| Event ID | 89461 |
| Event 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 |
| Product Type | Devices |
| Distribution | International distribution in the countries of Japan and the United Kingdom. |
| Quantity | 12 units |
| Recall Reason | Product was labelled with the incorrect manufacturing and distribution dates. |
| Device Classification | 20220309 |
| Device Code Info | Model No. DCS2825126; Lot No. 11012187061566009 |
| Center Classification Date | 20220225 |
| Recall Initiation Date | 20220209 |
| Recalling Firm | Wright Medical Technology, Inc. |
| Initial Notification | |
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