medical Class II Updated 2020-11-25

Medicrea International recalls MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to pro

Recalled Product

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

Hazard / Issue

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 ,

Issued by

FDA

Affected States: CA
Lot/Code Info: Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964
View official government recall

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