FDAClass IIMarch 9, 2022

The DARCO¿ Locking Bone Plate System is designed with recall

The DARCO¿ Locking Bone Plate System is designed with rhombus (parallelogram) plates of biocompatible titanium. The plates use either 2.7mm or 3.5mm…

Why was The DARCO¿ Locking Bone Plate System is designed with recalled?

Product was labelled with the incorrect manufacturing and distribution dates.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model No. DCS2825126; Lot No. 11012187061566009

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…
Recalling firm
Wright Medical Technology, Inc.
Quantity
12 units
Distribution
International distribution in the countries of Japan and the United Kingdom.
Recall date
March 9, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls