FDAClass IIMay 26, 2021

Easynject recall

EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS

Why was Easynject recalled?

Products labeled as sterile were distributed, but may not have been 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?

BATCH:2003721

Product
EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS
Recalling firm
BIOPSYBELL S.R.L.
Quantity
5 units
Distribution
US Nationwide distribution in the states MS and KY.
Recall date
May 26, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls