FDAClass IISeptember 27, 2023

Smith&nephew Legion Oxinum Posterior Stabilized recall

smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint

Why was Smith&nephew Legion Oxinum Posterior Stabilized recalled?

The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

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?

UDI/DI: 00885556234006, Lot Number: 23EM09878

Product
smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
Recalling firm
Smith & Nephew Inc
Quantity
8 units
Distribution
OH, CT, TX, NC, CA, NE, NV
Recall date
September 27, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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