PASS LP — Class II medical device recall Z-2458-2023
Ongoing recall by Medicrea International, reported 2023-08-30, distributed nationwide. There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the in
| Recall number | Z-2458-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicrea International, Rillieux La Pape, N/A, France |
| Recall initiated | 2023-07-12 |
| Classified | 2023-08-24 |
| Reported by FDA | 2023-08-30 |
| Distributed | Nationwide (US) |
| Quantity | 963 units |
| UPC / GTIN / UDI-DI | 03613720185086, 03613720185116, 03613720185147, 03613720185178, 03613720185321, 03613720185352, 03613720185383, 03613720185413, 03613720185598, 03613720185628, 03613720185659 |
| Lot numbers | 18D1035, 18E0322, 18E0478, 18E0508, 18F0534, 18F1011, 18G0170, 18G0591, 18G0704, 18H0588, 18H0617, 18H0672, 18I0682, 18I0780, 18J0054, 18J0215, 18K0278, 18K0279, 18K0862, 18K0863, 18K0864, 18K0865, 19A0066, 19A0645, 19B0091, 19B0093, 19B0318, 19B0731, 19B0777, 19B0912, 19C0138, 19C0417, 19C0739, 19D0177, 19D0267, 19E0082, 19E0084, 19E0306, 19F0460, 19G0188 and 49 more |
Product
PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2458-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.