PlainRecalls
FDA Devices Moderate Class II Completed

CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051

Reported: May 26, 2021 Initiated: March 22, 2021 #Z-1635-2021

Product Description

CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051

Reason for Recall

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

Details

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

Frequently Asked Questions

What product was recalled?
CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051. Recalled by BIOPSYBELL S.R.L.. Units affected: 500 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-1635-2021.