Device recall: MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for…

Class II FDA enforcement event 86657. Recall start date: 8 Oct 2020. Status in the FDA record: Terminated. Termination date: 9 May 2024.

Reason for recall, in the words of FDA

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 ,

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Medicrea International started this device recall on 8 Oct 2020. The firm address in the FDA record is in Rillieux La Pape. FDA put the recall in Class II. FDA event 86657 has 1 product record. The first FDA enforcement report date is 25 Nov 2020. The record gives the status Terminated, with the termination date 9 May 2024.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

CA Foreign:France, Belgium

Recalling firm

Medicrea International, Rillieux La Pape, N/A, France.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 86657: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0463-2021	MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200	17 units US; 8 units OUS Expanded: 1 US and 3 OUS	Class II	Terminated	25 Nov 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 9

Other events of the firm

Other FDA enforcement events of Medicrea International
Initiated	Product (first record)	Type	Class	Records
29 Oct 2025	Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000	Device	Class II	2
3 Dec 2024	UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based s	Device	Class II	1
12 Jul 2023	IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242	Device	Class II	11
28 Jan 2020	Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B3600	Device	Class II	2
11 Nov 2019	Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500	Device	Class II	1
2 Oct 2019	Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010	Device	Class II	1
16 Sep 2019	Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130	Device	Class II	2
27 Jun 2019	Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIA	Device	Class II	1

Medicrea International: all 9 events

Official channels

FDA enforcement report Z-0463-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 86657. https://recallregister.com/fda/ii/86657/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: CA Foreign:France, Belgium
What quantity of product is in FDA event 86657?: The FDA record gives this quantity: 17 units US; 8 units OUS Expanded: 1 US and 3 OUS
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.