PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: March 9, 2022 Initiated: February 9, 2022 #Z-0679-2022

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.

Details

Units Affected
12 units
Distribution
International distribution in the countries of Japan and the United Kingdom.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Wright Medical Technology, Inc.. Units affected: 12 units.
Why was this product recalled? ▼
Product was labelled with the incorrect manufacturing and distribution dates.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 9, 2022. Severity: Moderate. Recall number: Z-0679-2022.

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