FDAClass IINovember 13, 2013

Genesis(r) II recall

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic

Why was Genesis(r) II recalled?

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

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 No. 13GM09505

Product
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Recalling firm
Smith & Nephew Inc
Quantity
4 units
Distribution
USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
Recall date
November 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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