FDAClass IIFebruary 12, 2020

WRIGHT EVOLVE Proline Head recall

WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

Why was WRIGHT EVOLVE Proline Head recalled?

Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

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?

Lot code 1633303

Product
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Recalling firm
Wright Medical Technology, Inc.
Quantity
48 devices
Distribution
US
Recall date
February 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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