FDAClass IIJuly 30, 2014

NOVATION Femoral Stem recall

NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint…

Why was NOVATION Femoral Stem recalled?

The femoral stem is lacking specified plasma coating.

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?

Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252

Product
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint…
Recalling firm
Exactech, Inc.
Quantity
10
Distribution
Worldwide Distribution including Spain, Greece and Japan
Recall date
July 30, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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