CLASS II ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report

Impix C+ recalled by Medicrea International

Medicrea International is recalling Impix C+, distributed nationwide in the US. The recall was initiated on 12 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) B20240104, GTIN 03613720234241, Lot Numbers: 19A0773, 19B0524, 19C0511, 19E0477, 19K0180; b) B20240105, GTIN 03613720234258, Lot Numbers: 18K0653, 18L0497, 19A0636, 19A0654, 19B0189, 19C0512, 19C0664, 19I0849, 19L0701, 20G0851, 20H0262, 20I0570, 20I0877, 21D0764; c) B20240106, GTIN 03613720234265, Lot Numbers: 18C0676R, 18C0677, 18D0172, 19E0573, 19K0687, 20B0586, 20H0263, 20J0077, 21D0148, 21J0504, 22B0181; d) B20240107, GTIN 03613720234272, Lot Numbers: 18D0174, 18L0401, 18L0498, 19D0672, 19E0087, 19G1092, 19K0478, 20B0587, 20H0264, 21H0507, 22B0485; e) B20240205, GTIN 03613720234319, Lot Numbers: 22D0384, 22G0443; f) B20240206, GTIN 03613720234326, Lot Numbers: 20H0265, 22B0182; g) B20240207, GTIN 03613720234333, Lot Numbers: 18I0761, 18J0489, 19C0513, 20A0488, 20H0266; h) B20240208, GTIN 03613720234340, Lot Numbers: 18K0298, 19D0565, 19I0617, 20C0164, 20H0267, 22A0736

Quantity recalled0 (US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2460-2023
FDA event ID: 92738
Recalling firm: Medicrea International, Rillieux La Pape, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 12 Jul 2023
FDA classified: 24 Aug 2023
Reported: 30 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Spinal Implants

Timeline

12 Jul 2023	Recall initiated by company
24 Aug 2023	Classified by FDA	+43 days
30 Aug 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical

Where it was distributed

US nationwide

Nationwide

Questions about this recall

Is Impix C+ recalled?

Yes. Medicrea International recalled Impix C+ on 12 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2460-2023.

Why was it recalled?

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

Which lots are affected?

a) B20240104, GTIN 03613720234241, Lot Numbers: 19A0773, 19B0524, 19C0511, 19E0477, 19K0180; b) B20240105, GTIN 03613720234258, Lot Numbers: 18K0653, 18L0497, 19A0636, 19A0654, 19B0189, 19C0512, 19C0664, 19I0849, 19L0701, 20G0851, 20H0262, 20I0570, 20I0877, 21D0764; c) B20240106, GTIN 03613720234265, Lot Numbers: 18C0676R, 18C0677, 18D0172, 19E0573, 19K0687, 20B0586, 20H0263, 20J0077, 21D0148, 21J0504, 22B0181; d) B20240107, GTIN 03613720234272, Lot Numbers: 18D0174, 18L0401, 18L0498, 19D0672, 19E0087, 19G1092, 19K0478, 20B0587, 20H0264, 21H0507, 22B0485; e) B20240205, GTIN 03613720234319, Lot Numbers: 22D0384, 22G0443; f) B20240206, GTIN 03613720234326, Lot Numbers: 20H0265, 22B0182; g) B20240207, GTIN 03613720234333, Lot Numbers: 18I0761, 18J0489, 19C0513, 20A0488, 20H0266; h) B20240208, GTIN 03613720234340, Lot Numbers: 18K0298, 19D0565, 19I0617, 20C0164, 20H0267, 22A0736

Where was it sold?

US nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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