FDAClass IIMay 26, 2021

BPB Medica Renova Spine Kyphoplasty Working Cannula and recall

BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US

Why was BPB Medica Renova Spine Kyphoplasty Working Cannula and 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: 20061307

Product
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
Recalling firm
BIOPSYBELL S.R.L.
Quantity
10 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