FDA Device recall Z-0679-2022
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium by Wright Medical Technology, citing product was labelled with the incorrect manufacturing and distribution dates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0679-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-09 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wright Medical Technology |
| Distribution | n/a |
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
Product was labelled with the incorrect manufacturing and distribution dates.
Identifiers
| code_info | Model No. DCS2825126; Lot No. 11012187061566009 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0679-2022%22
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