FDA recall Z-0463-2021

Product

MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200

Reason for recall

Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of infection and re-intervention ,

Distribution

CA Foreign:France, Belgium

Key facts

Status

Terminated

Initiation date

2020-10-08

Report date

2020-11-25

Termination date

2024-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rillieux La Pape, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0463-2021