FDA-Device2020-11-25Class II
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Medicrea International
Hazard
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 ,
Sold states
CA Foreign:France, Belgium
Affected count
17 units US; 8 units OUS Expanded: 1 US and 3 OUS
Manufactured in
Vancia, Vancia, Rillieux La Pape, N/A, France
Products
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0463-2021Don't want to check this manually?
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