FDA recall Z-1729-2021

Product

ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For use in Orthopedic / spinal procedures.

Reason for recall

Products distributed as sterile may not have been adequately sterilized

Distribution

US nationwide distribution.

Key facts

Status

Terminated

Initiation date

2021-03-25

Report date

2021-06-09

Termination date

2023-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Flowood, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1729-2021