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IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B...

FDA Device Recall #Z-2456-2023 — Class II — July 12, 2023

Recall Summary

Recall Number Z-2456-2023
Classification Class II — Moderate risk
Date Initiated July 12, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medicrea International
Location Rillieux La Pape, N/A
Product Type Devices
Quantity 4489 units

Product Description

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

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.

Distribution Pattern

US nationwide

Lot / Code Information

a) A20150407, GTIN 03613720236016, Lot Numbers: 18F0803, 18J0713, 18J0714, 19A0225, 19A0786, 19A0787, 19D0381, 19D0382, 19J0594, 20A0280, 20H0285, 20I0475, 20K0424, 21D0442, 21I0596, 22E0637; b) A20250407, GTIN 03613720236078, Lot Numbers: 18E0532, 18I0840, 18I0841, 18K0067, 18K0068, 18L0399, 19A0371, 19A0372, 19C0587, 19D0383, 19D0384, 19J0592, 19J0746, 19K0731, 19K0853, 20A0281, 20C0260, 20F0920, 20H0286, 20I0476, 20J0558, 20K0425, 21D0858, 21F0990, 21I0598, 22C0262, 22C0268, 22D0732, 22E0638, 22E0640, 22E0642, 22E0656, 22F0408, 22F0409; c) A20350567, GTIN 03613720236108, Lot Numbers: 18K0069, 19B0752, 19D0745, 20A0279, 20F0922, 20I0477, 21D0443, 21G0784, 22D0733, 22G0683; d) B20181743, GTIN 03613720233251, Lot Numbers: 19D0208, 19E0604, 19K0588; e) B20181753, GTIN 03613720233275, Lot Numbers: 20G0209, 20I0486, 20L0199, 21C0843; f) B20181763, GTIN 03613720233305, Lot Numbers: 18L0570, 19D0100, 19G0205, 19J0470, 20A0645; g) B20181773, GTIN 03613720233336, Lot Numbers: 19A0830, 19J0611, 19L0612, 20I0831; h) B20181943, GTIN 03613720233442, Lot Numbers: 19K0878, 20E0094, 21G0420; i) B20181953, GTIN 03613720233466, Lot Numbers: 21K0501; j) B20181963, GTIN 03613720233497, Lot Numbers: 21K0502; k) B20181973, GTIN 03613720233527, Lot Numbers: 21C0844; l) B20182253, GTIN 03613720233657, Lot Numbers: 19J0471, 19J0711, 20I0832; m) B20182263, GTIN 03613720233688, Lot Numbers: 22D0811

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Z-1039-2026 Class II Medicrea, IB3D PL Instruments Set, Rx Only REF... Oct 29, 2025
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Z-1118-2025 Class II UNiD" Adaptive Spine Intelligence UNiD Spine... Dec 3, 2024
Z-2453-2023 Class II IMPIX ALIF, REF numbers: a) B15111209, b)... Jul 12, 2023
Z-2461-2023 Class II IMPIX S, REF numbers: a) B15328071S, b) B1... Jul 12, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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