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MEDICREA INTERNATIONAL FDA Inspection Record

FEI 1000432246 · Inspections, Form 483s, warning letters and import refusals

MEDICREA INTERNATIONAL is an FDA-registered facility (FEI 1000432246) located in RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FR. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Feb 16, 2017: Voluntary Action Indicated (VAI)
Inspections on record
3 (3 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
9, latest Oct 29, 2025
Import refusals
4

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Feb 16, 2017Voluntary Action Indicated (VAI)Design verification - output does not meet input requirement (21 CFR 820.30(f))
Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))
Investigation of device failures (21 CFR 820.198(c))
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
and 1 more
Jun 20, 2013Voluntary Action Indicated (VAI)No citations listed
Jun 19, 2013Voluntary Action Indicated (VAI)Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of or inadequate instructions (21 CFR 820.170(a))
Records, DHR {see also 820.184(e)} (21 CFR 820.120(d))
Distributor responsibilities for complaint records (21 CFR 803.18(d)(1))
and 1 more

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 29, 2025Class IIZ-1038-2026Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 and 1 more product
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Dec 3, 2024Class IIZ-1118-2025UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code…
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that…
Jul 12, 2023Class IIZ-2452-2023IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810… and 10 more products
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Oct 8, 2020Class IIZ-0463-2021MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar…
Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and…
Jan 28, 2020Class IIZ-1472-2020Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540… and 1 more product
An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or…
Nov 11, 2019Class IIZ-1234-2020Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal]…
Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
Oct 2, 2019Class IIZ-1156-2020Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog…
Inner draw rod, which threads into the cage may potentially be separated from the proximal knob of the inserter
Sep 16, 2019Class IIZ-0827-2020Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130 and 1 more product
Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
Jun 27, 2019Class IIZ-0753-2020Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE…
It has been determined that some Pedicle system screw identified as 45mm long have an actual length of 50mm. Pedicle screws with a diameter…

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Medicrea International
Location
RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes (FR)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.