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

Impix Tlif recalled by Medicrea International

Medicrea International is recalling Impix Tlif, 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) B15130607S, GTIN 03613720245681, Lot Numbers: 19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479; b) B15130609S, GTIN 03613720245674, Lot Numbers: 18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734; c) B15130611S, GTIN 03613720193760, Lot Numbers: 19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732; d) B15130613S, GTIN 03613720193784, Lot Numbers: 18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909; e) B15130615S, GTIN 03613720193807, Lot Numbers: 20I0097; f) B15900806, GTIN 03613720275572, Lot Numbers: 19A0329R; g) B15900906, GTIN 03613720275589, Lot Numbers: 19A0340R; h) B15901006, GTIN 03613720275596, Lot Numbers: 19A0339R; i) B15901106, GTIN 03613720275602, Lot Numbers: 19A0338R, 19G0337; j) B15901206, GTIN 03613720275619, Lot Numbers: 19A0337R; k) B15901306, GTIN 03613720275626, Lot Numbers: 19A0336R

Quantity recalled730 units

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-2457-2023
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 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

Where it was distributed

US nationwide

Nationwide

Questions about this recall

Is Impix Tlif recalled?

Yes. Medicrea International recalled Impix Tlif on 12 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2457-2023.

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) B15130607S, GTIN 03613720245681, Lot Numbers: 19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479; b) B15130609S, GTIN 03613720245674, Lot Numbers: 18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734; c) B15130611S, GTIN 03613720193760, Lot Numbers: 19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732; d) B15130613S, GTIN 03613720193784, Lot Numbers: 18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909; e) B15130615S, GTIN 03613720193807, Lot Numbers: 20I0097; f) B15900806, GTIN 03613720275572, Lot Numbers: 19A0329R; g) B15900906, GTIN 03613720275589, Lot Numbers: 19A0340R; h) B15901006, GTIN 03613720275596, Lot Numbers: 19A0339R; i) B15901106, GTIN 03613720275602, Lot Numbers: 19A0338R, 19G0337; j) B15901206, GTIN 03613720275619, Lot Numbers: 19A0337R; k) B15901306, GTIN 03613720275626, Lot Numbers: 19A0336R

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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