Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

The DARCO¿ Locking Bone Plate System is designed with rhombus Recalled by Wright Medical Technology, Inc. Due to Product was labelled with the incorrect manufacturing and...

Date: February 9, 2022
Company: Wright Medical Technology, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Wright Medical Technology, Inc. directly.

Affected Products

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

Quantity: 12 units

Why Was This Recalled?

Product was labelled with the incorrect manufacturing and distribution dates.

Where Was This Sold?

International distribution in the countries of Japan and the United Kingdom.

About Wright Medical Technology, Inc.

Wright Medical Technology, Inc. has 69 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report