Recall archive / FDA device enforcement
The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The p... — FDA record Z-0679-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 12 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0679-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model No. DCS2825126; Lot No. 11012187061566009 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of Japan and the United Kingdom.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Mar 9, 2022
- Recall initiation date
- Feb 9, 2022
- Center classification date
- Feb 25, 2022
- Termination date
- Jan 25, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.