FDAClass IIJuly 20, 2022

Wright EVOLVE TRIAD Plate Cutter recall

Wright EVOLVE TRIAD Plate Cutter, REF 49510120

Why was Wright EVOLVE TRIAD Plate Cutter recalled?

The plate cutter is unable to meet sterilization requirements when it is sterilized in a double-wrapped configuration according to the Option 1 Steam Sterilization parameters detailed in instructions for use

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Lot codes: 955401, 1168853, 1349302, 1956936, 2486857

Product
Wright EVOLVE TRIAD Plate Cutter, REF 49510120
Recalling firm
Wright Medical Technology, Inc.
Quantity
231
Distribution
Nationwide and PR, and Australia, Canada, Chile, Colombia, Hong Kong, Puerto Rico
Recall date
July 20, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls