FDA Device recall Z-2454-2023
IMPIX ALIF S/A, REF number B15241415
- FDA Device
- Class II
- ongoing
- Published 2023-08-30
On 2023-08-30 the FDA classified a Class II recall of IMPIX ALIF S/A, REF number B15241415 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-2454-2023 |
| 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 ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
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 | GTIN 03613720264439, Lot Numbers: 18I0824, 19L0046 |
|---|
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-2454-2023%22
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