FDA recall Z-1636-2021

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states MS and KY.

Key facts

Status

Terminated

Initiation date

2021-03-22

Report date

2021-05-26

Termination date

2026-02-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mirandola, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2021