Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic Recalled by Medicrea International Due to Tightening the LIGAPASS Band with this instrument, the...

Date: October 8, 2020
Company: Medicrea International
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medicrea International directly.

Affected Products

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

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

Why Was This Recalled?

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 ,

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Medicrea International

Medicrea International has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report