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Medicrea International recalls MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for dege
Recalled November 25, 2020 · FDA recall Z-0463-2021 · 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 , · FDA Class II
Units
17 units US; 8 units OUS Expanded: 1 US and 3 OUS
Sold at
CA Foreign:France, Belgium
Description
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 ,
Product
MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
Manufacturer(s)
Medicrea International
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →