Medicrea International: Medical Device Recall in 2020 - (Recall #: Z-0463-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 8, 2020

Date Posted: November 25, 2020

Recall Number: Z-0463-2021

Event ID: 86657

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 ,

Status: Terminated

Product Quantity: 17 units US; 8 units OUS Expanded: 1 US and 3 OUS

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

Distribution Pattern:

CA Foreign:France, Belgium

Voluntary or Mandated:

Voluntary: Firm initiated