Recall Register

Medicrea International: FDA recalls

FDA enforcement reports name Medicrea International as the recalling firm in 9 events. The events have 22 product records. The recalls started from 2019 to 2025. All the events are device recalls.

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 . openFDA export of .

Enforcement events

9 events, newest first.

FDA enforcement events of Medicrea International
InitiatedProduct (first record)TypeClassRecordsStatus
29 Oct 2025Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000DeviceClass II2Ongoing
3 Dec 2024UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer,…DeviceClass II1Ongoing
12 Jul 2023IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q)…DeviceClass II11Ongoing
8 Oct 2020MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200DeviceClass II1Terminated
28 Jan 2020Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560 B36007535 B36007540 B36007545 B36007550 B36007555 B36007560…DeviceClass II2Terminated
11 Nov 2019Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500DeviceClass II1Terminated
2 Oct 2019Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010DeviceClass II1Terminated
16 Sep 2019Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130DeviceClass II2Ongoing
27 Jun 2019Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PARAFUSO PEDICULAR POLIAXIAL 7.5MM x 45MM,…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

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

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

Type and class

Medicrea International: events for each product type
TypeEvents
Device9
Medicrea International: events in each class
ClassEvents
Class II9
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
4

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.

Events by year

FDA enforcement events of Medicrea International, by the year that the recall started. The largest year is 2019, with 4 events.

Official channels

Cite this page

Recall Register. Medicrea International: FDA recalls. https://recallregister.com/firm/medicrea-international/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Medicrea International have?
Class II: 9 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Medicrea International?
FDA event 97996, which the firm started on 29 Oct 2025. The first product in the record is: Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
How many FDA recalls of Medicrea International have the status Ongoing?
4 events have the status Ongoing in the openFDA file. openFDA says 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.