FDA recall Z-1156-2020

Medicrea International · Class II · device

Product

Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010

Reason for recall

Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter

Distribution

OH, VA

Key facts

Status
Terminated
Initiation date
2019-10-02
Report date
2020-02-19
Termination date
2021-02-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rillieux La Pape, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1156-2020