🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: July 12, 2023 Medicrea International Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    a) B20171743, GTIN 03613720232636, Lot Numbers: 18E0275, 18E0404, 18E0676, 18E0833, 18I0867, 18K0143, 18L0219, 19A0463, 19A0669, 19B0870, 19D0484, 19G0192, 19G0422, 19J0468, 19L0381, 20F0631, 20G0849, 20H0596, 20H0597, 20H0598, 20I0875, 20J0772, 21I0163, 22A0172, 22D0807, 22E0264, 22G0048, 22G0477, 22I0342; b) B20171753, GTIN 03613720232667, Lot Numbers: 18H0597, 18K0137, 18K0831, 18L0488, 19A0324, 19A0325, 19B0362, 19B0470, 19D0485, 19E0322, 19G0204, 19G0423, 19I0274, 19J0273, 19L0382, 20F0632, 20F0633, 20H0600, 20H0601, 20H0602, 20H0603, 20I0222, 21C0104, 21F0651, 21I0511, 22I0615, 22J0265; c) B20171763, GTIN 03613720232698, Lot Numbers: 18E0405, 18E0834, 18G0422, 18H0572, 18J0063, 18K0066, 18L0070, 18L0489, 19A0215, 19A0425, 19B0687, 19C0653, 19D0486, 19E0436, 19G0830, 19I0842, 19L0383, 20F0634, 20H0594, 20H0595, 21E0234, 21G0482, 22I0343; d) B20171773, GTIN 03613720232728, Lot Numbers: 19C0591, 19F0579, 19H0089, 19J0272, 20F0635, 20H0249, 22G0571; e) B20171943, GTIN 03613720232841, Lot Numbers: 18C0552, 18E0835, 18I0712, 18K0897, 18L0490, 19A0670, 19B0680, 19D0251, 19G0302, 19I0582, 20A0644, 20F0636, 20H0599, 20I0487, 21H0101, 22A0173, 22B0482, 22D0808, 22E0808; f) B20171953, GTIN 03613720232872, Lot Numbers: 18E0483, 18E0677, 18E0836, 18J0103, 18K0144, 18L0400, 19A0159, 19A0671, 19A0675, 19B0089, 19D0487, 19D0637, 19F0103, 19G0303, 19H0375, 19I0843, 19K0586, 20A0200, 20C0163, 20F0637, 20H0251, 20H0254, 20H0255, 20J0062, 20J0065, 20J0368, 21F0551, 21I0177, 22B0786, 22E0263, 22E0809, 22F0490, 22F0492, 22G0440, 22H0055, 22J0202; g) B20171963, GTIN 03613720232902, Lot Numbers: 18K0158, 18L0491, 19A0672, 19A0829, 19C0146, 19D0262, 19E0437, 19G0424, 19H0376, 19I0234, 19K0832, 19L0613, 20A0969, 20F0638, 20H0604, 20H0605, 20H0606, 20H0607, 20I0705, 20J0068, 21F0155, 22D0809, 22G0441, 22H0643, 22J0203,; h) B20171973, GTIN 03613720232933, Lot Numbers: 18D0171, 18F0203, 18I0466, 18K0136, 18L0492, 19A0673, 19D0488, 19I0844, 20H0257, 21A0064, 22D0385, 22F1090, 22G0442; i) B20172253, GTIN 03613720233084, Lot Numbers: 18E0406, 18K0140, 18K0898, 19A0214, 19B0174, 19C0728, 19E0438, 19I0583, 20H0258, 20K0542, 21G0760; j) B20172263, GTIN 03613720233114, Lot Numbers: 18D1078, 18G0423, 18K0159, 18L0220, 19A0069, 19B0175, 19E0439, 19I0845, 20A0995, 20F0386, 20H0593, 20J0127, 21F0247, 21J0503; k) B20172273, GTIN 03613720233145, Lot Numbers: 18K0160, 18K0608, 19A0079, 19B0471, 19C0729, 19D0671, 19J0469, 20H0259, 22B0180, 22B0484, 22E0095
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medicrea International
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

a) B20171743, GTIN 03613720232636, Lot Numbers: 18E0275, 18E0404, 18E0676, 18E0833, 18I0867, 18K0143, 18L0219, 19A0463, 19A0669, 19B0870, 19D0484, 19G0192, 19G0422, 19J0468, 19L0381, 20F0631, 20G0849, 20H0596, 20H0597, 20H0598, 20I0875, 20J0772, 21I0163, 22A0172, 22D0807, 22E0264, 22G0048, 22G0477, 22I0342; b) B20171753, GTIN 03613720232667, Lot Numbers: 18H0597, 18K0137, 18K0831, 18L0488, 19A0324, 19A0325, 19B0362, 19B0470, 19D0485, 19E0322, 19G0204, 19G0423, 19I0274, 19J0273, 19L0382, 20F0632, 20F0633, 20H0600, 20H0601, 20H0602, 20H0603, 20I0222, 21C0104, 21F0651, 21I0511, 22I0615, 22J0265; c) B20171763, GTIN 03613720232698, Lot Numbers: 18E0405, 18E0834, 18G0422, 18H0572, 18J0063, 18K0066, 18L0070, 18L0489, 19A0215, 19A0425, 19B0687, 19C0653, 19D0486, 19E0436, 19G0830, 19I0842, 19L0383, 20F0634, 20H0594, 20H0595, 21E0234, 21G0482, 22I0343; d) B20171773, GTIN 03613720232728, Lot Numbers: 19C0591, 19F0579, 19H0089, 19J0272, 20F0635, 20H0249, 22G0571; e) B20171943, GTIN 03613720232841, Lot Numbers: 18C0552, 18E0835, 18I0712, 18K0897, 18L0490, 19A0670, 19B0680, 19D0251, 19G0302, 19I0582, 20A0644, 20F0636, 20H0599, 20I0487, 21H0101, 22A0173, 22B0482, 22D0808, 22E0808; f) B20171953, GTIN 03613720232872, Lot Numbers: 18E0483, 18E0677, 18E0836, 18J0103, 18K0144, 18L0400, 19A0159, 19A0671, 19A0675, 19B0089, 19D0487, 19D0637, 19F0103, 19G0303, 19H0375, 19I0843, 19K0586, 20A0200, 20C0163, 20F0637, 20H0251, 20H0254, 20H0255, 20J0062, 20J0065, 20J0368, 21F0551, 21I0177, 22B0786, 22E0263, 22E0809, 22F0490, 22F0492, 22G0440, 22H0055, 22J0202; g) B20171963, GTIN 03613720232902, Lot Numbers: 18K0158, 18L0491, 19A0672, 19A0829, 19C0146, 19D0262, 19E0437, 19G0424, 19H0376, 19I0234, 19K0832, 19L0613, 20A0969, 20F0638, 20H0604, 20H0605, 20H0606, 20H0607, 20I0705, 20J0068, 21F0155, 22D0809, 22G0441, 22H0643, 22J0203,; h) B20171973, GTIN 03613720232933, Lot Numbers: 18D0171, 18F0203, 18I0466, 18K0136, 18L0492, 19A0673, 19D0488, 19I0844, 20H0257, 21A0064, 22D0385, 22F1090, 22G0442; i) B20172253, GTIN 03613720233084, Lot Numbers: 18E0406, 18K0140, 18K0898, 19A0214, 19B0174, 19C0728, 19E0438, 19I0583, 20H0258, 20K0542, 21G0760; j) B20172263, GTIN 03613720233114, Lot Numbers: 18D1078, 18G0423, 18K0159, 18L0220, 19A0069, 19B0175, 19E0439, 19I0845, 20A0995, 20F0386, 20H0593, 20J0127, 21F0247, 21J0503; k) B20172273, GTIN 03613720233145, Lot Numbers: 18K0160, 18K0608, 19A0079, 19B0471, 19C0729, 19D0671, 19J0469, 20H0259, 22B0180, 22B0484, 22E0095

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2462-2023

Related Recalls

UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.

Medicrea International

Class I - Dangerous

Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.

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