FDA Device recall Z-2462-2023

IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973,…

FDA Device
Class II
ongoing
Published 2023-08-30

On 2023-08-30 the FDA classified a Class II recall of IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B20171953, g) B20171963, h) B20171973,… by Medicrea International, citing there is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2462-2023
Classification	Class II
Status	ongoing
Initiated	2023-07-12
Published	2023-08-30
Last updated	2026-09-13 11:56 UTC
Company	Medicrea International
Distribution	US

Product

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

Reason

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

Identifiers

code_info	a) B20171743, GTIN 03613720232636, Lot Numbers: 18E0275, 18E0404, 18E0676, 18E0833, 18I0867, 18K0143, 18L0219, 19A0463… 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 0361372

code_info

a) B20171743, GTIN 03613720232636, Lot Numbers: 18E0275, 18E0404, 18E0676, 18E0833, 18I0867, 18K0143, 18L0219, 19A0463…

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 0361372

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2462-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.