FDAClass IIJune 20, 2018

smith&nephew GENESIS(R) II TIBIAL Punch recall

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Why was smith&nephew GENESIS(R) II TIBIAL Punch recalled?

One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

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?

15FM16181

Product
smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Recalling firm
Smith & Nephew, Inc.
Quantity
5 units
Distribution
International only: United Arab Emirates, Spain, Mexico
Recall date
June 20, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls