Device recall: IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f)…

Class II FDA enforcement event 92738. Recall start date: 12 Jul 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

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 12 Jul 2023. The firm address in the FDA record is in Rillieux La Pape. FDA put the recall in Class II. FDA event 92738 has 11 product records. The first FDA enforcement report date is 30 Aug 2023. The record gives the status Ongoing.

FDA enforcement report The 11 product records

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.

US nationwide

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

11 product records in the event.

FDA event 92738: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2452-2023	IMPIX 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)…	248 units	Class II	Ongoing	30 Aug 2023
Z-2453-2023	IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar	11 units	Class II	Ongoing	30 Aug 2023
Z-2454-2023	IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar	5 units	Class II	Ongoing	30 Aug 2023
Z-2455-2023	IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar	24 units	Class II	Ongoing	30 Aug 2023
Z-2456-2023	IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, g) B20181773, h) B20181943, i) B20181953, j) B20181963, k) B20181973, l) B20182253, m) B20182263; intervertebral fusion device - lumbar	4489 units	Class II	Ongoing	30 Aug 2023
Z-2457-2023	IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar	730 units	Class II	Ongoing	30 Aug 2023
Z-2458-2023	PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical	963 units	Class II	Ongoing	30 Aug 2023
Z-2459-2023	GRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e) A13131789, f) A13132012, g) B13111014, h) B13111015, i) B13111016, j) B13111017, k) B13111025, l) B13111026, m) B13111027, n) B13111034, o) B13111035, p) …	O (US)	Class II	Ongoing	30 Aug 2023
Z-2460-2023	IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical	0 (US)	Class II	Ongoing	30 Aug 2023
Z-2461-2023	IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical	0 (US)	Class II	Ongoing	30 Aug 2023
Z-2462-2023	IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973, i) B20172253, j) B20172263, k) B20172273; intervertebral fusion device - cervical	N/A	Class II	Ongoing	30 Aug 2023

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 2023: 917
Share of these events in Class II: 88%
Product records in this event: 11Median 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
8 Oct 2020	MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degen	Device	Class II	1
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-2452-2023The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 92738. https://recallregister.com/fda/ii/92738/. 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: US nationwide
What quantity of product is in FDA event 92738?: The event has 11 product records. The first record gives this quantity: 248 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?: 88% of the 917 device events that started in 2023 are in Class II.