Recall Z-0463-2021— Medicrea International
Class II · Terminated
Class II FDA medical device recall by Medicrea International, initiated 2020-10-08, terminated 2024-05-09. FDA's recall record names no specific 510(k) clearance for this event. Product: MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200. Reason: 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 ,.
- Recalling firm
- Medicrea International
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-10-08
- Terminated
- 2024-05-09
- Firm location
- Rillieux La Pape, N/A, France
Product description
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 ,
Data sourced from openFDA. This site is unofficial and independent of the FDA.