FDAClass IINovember 22, 2017

smith&nephew LEGION L-WEDGE recall

smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components…

Why was smith&nephew LEGION L-WEDGE recalled?

The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

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 14GSM0440A

Product
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components…
Recalling firm
Smith & Nephew, Inc.
Quantity
10 units
Distribution
US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand
Recall date
November 22, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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