FDAClass IIDecember 27, 2023

Exactech Novation Hip System recall

Exactech Novation Hip System, Catalog Numbers: 134-36-45

Why was Exactech Novation Hip System recalled?

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

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?

GTIN 10885862024046, Serial Numbers: A763009, A763010, A763011, A763017, A763018, A763020

Product
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Recalling firm
Exactech, Inc.
Quantity
N/A
Distribution
US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and Australia, Brazil, Chile, France, Germany, Guatemala, Italy, Japan, Korea, Slovenia, Spain, UK
Recall date
December 27, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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