Z-0679-2022 Class II Terminated
FDA device recall Z-0679-2022 was initiated by Wright Medical Technology, Inc. on Feb 9, 2022 and is designated Class II. Reason for recall: Product was labelled with the incorrect manufacturing and distribution dates. The recall status is terminated (terminated Jan 25, 2024). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 9, 2022
- Initiation Date
- Feb 9, 2022
- Termination Date
- Jan 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0679-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026