FDAClass IIMay 30, 2018

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular recall

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery…

Why was smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular recalled?

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

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?

Batch Numbers: 08BM09288; 12EM05884 & 12EM07720

Product
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery…
Recalling firm
Smith & Nephew, Inc.
Quantity
47 units
Distribution
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Recall date
May 30, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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