FDAClass IIJune 9, 2021

REF 4049 Micross recall: Sterility Concern

REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

Why was REF 4049 Micross recalled?

Sterility issues; single use devices labeled as sterile may not have been adequately sterilized

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?

Lot number: 2-01121, 23-28920, 21-26520, 18-24819, 24-29118, 21-24818, 13-12818, 26-33118

Product
REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.
Recalling firm
Meta C.G.M. Spa
Quantity
1,692
Distribution
Distribution in US states of Texas and Florida
Recall date
June 9, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
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