FDAClass IIAugust 30, 2023

Impix S recall

IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device…

Why was Impix S 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?

a) B15328071S, GTIN 03613720195535, Lot Numbers: 19I0696, 20A0759; b) B15328073S, GTIN 03613720195573, Lot Numbers: 20B0747; c) B15328074S, GTIN 03613720195597, Lot Numbers: 19I0698; d) B15334072S, GTIN 03613720195832, Lot Numbers: 19I0557, 20F0185; e) B15334073S, GTIN 03613720195856, Lot Numbers: 19J0947; f) B15334074S, GTIN 03613720195870, Lot Numbers: 19E0502, 19J0091, 20F0184

Product
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device…
Recalling firm
Medicrea International
Quantity
0 (US)
Distribution
US nationwide
Recall date
August 30, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls