FDA recall Z-1755-2021

Product

InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c) INTVMN-15-DSKC d) INTVMN-20-DSK. 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-1755-2021