Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
Why it was recalled
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
a) B15130607S, GTIN 03613720245681, Lot Numbers: 19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479; b) B15130609S, GTIN 03613720245674, Lot Numbers: 18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734; c) B15130611S, GTIN 03613720193760, Lot Numbers: 19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732; d) B15130613S, GTIN 03613720193784, Lot Numbers: 18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909; e) B15130615S, GTIN 03613720193807, Lot Numbers: 20I0097; f) B15900806, GTIN 03613720275572, Lot Numbers: 19A0329R; g) B15900906, GTIN 03613720275589, Lot Numbers: 19A0340R; h) B15901006, GTIN 03613720275596, Lot Numbers: 19A0339R; i) B15901106, GTIN 03613720275602, Lot Numbers: 19A0338R, 19G0337; j) B15901206, GTIN 03613720275619, Lot Numbers: 19A0337R; k) B15901306, GTIN 03613720275626, Lot Numbers: 19A0336R
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US nationwide
Recall record
- Recalling firm
- Medicrea International
- Product type
- Devices
- Recall number
- Z-2457-2023
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Rillieux La Pape, N/A
- Recall initiated
- 2023-07-12
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-2457-2023 · Source: openFDA enforcement.