FDAClass IINovember 27, 2024

NovoHip Biolox Ball Head 32mmL recall: Labeling Error

NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a…

Why was NovoHip Biolox Ball Head 32mmL recalled?

Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted

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?

UDI-DI 00811382037849; Lot Number CER0023

Product
NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a…
Recalling firm
Novosource, LLC
Quantity
1 unit
Distribution
Florida, West Virginia
Recall date
November 27, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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