FDAClass IIAugust 30, 2023

Impix Alif S/a recall

IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar

Why was Impix Alif S/a recalled?

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

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 03613720264439, Lot Numbers: 18I0824, 19L0046

Product
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
Recalling firm
Medicrea International
Quantity
5 units
Distribution
US nationwide
Recall date
August 30, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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