PlainRecalls
FDA Devices Moderate Class II Completed

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

Reported: May 26, 2021 Initiated: March 22, 2021 #Z-1633-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
BIOPSYBELL S.R.L.
Units Affected
10 units
Distribution
US Nationwide distribution in the states MS and KY.
Location
Mirandola, N/A

Frequently Asked Questions

What product was recalled?
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US. Recalled by BIOPSYBELL S.R.L.. Units affected: 10 units.
Why was this product recalled?
Products labeled as sterile were distributed, but may not have been sterilized.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 26, 2021. Severity: Moderate. Recall number: Z-1633-2021.