Home / Recalls / Medicrea International / Z-0463-2021

Z-0463-2021 Class II Terminated

Recalled by Medicrea International — Rillieux La Pape, N/A

Recall Details

Product Type
Devices
Report Date
November 25, 2020
Initiation Date
October 8, 2020
Termination Date
May 9, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 units US; 8 units OUS Expanded: 1 US and 3 OUS

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 ,

Distribution Pattern

CA Foreign:France, Belgium

Code Information

Lot Numbers: US: 17E0550-1, 17E1089R/2, 18E0278, OUS: 19B0962, 19B0595, 19B0601 Expanded Recall: 11/3/20 17E0550/2, 19B0602, 19B0963 and 19B0964

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