FDA Device recall Z-2460-2023
IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208
- FDA Device
- Class II
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208 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-2460-2023 |
| 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 C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; 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) B20240104, GTIN 03613720234241, Lot Numbers: 19A0773, 19B0524, 19C0511, 19E0477, 19K0180; b) B20240105, GTIN 03613…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 |
|---|
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-2460-2023%22
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