FDAClass IIMarch 25, 2020

Legion PS High Flex Xlpe recall

LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

Why was Legion PS High Flex Xlpe recalled?

LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part

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 Number 19FM12500; Product Number 71453221.

Product
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Recalling firm
Smith & Nephew, Inc.
Quantity
29 units
Distribution
USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).
Recall date
March 25, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls