Reported Aug 30, 2023 · Ongoing
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g)…
Medicrea International
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medicrea International · Vancia · Rillieux La Pape, N/A · N/A
Is this the product you have?
11 of 11 products
| # | Product as published |
|---|---|
| 1 | B15130607S |
| 2 | B15130609S |
| 3 | B15130611S |
| 4 | B15130613S |
| 5 | B15130615S |
| 6 | B15900806 |
| 7 | B15900906 |
| 8 | B15901006 |
| 9 | B15901106 |
| 10 | B15901206 |
| 11 | B15901306; intervertebral fusion device - lumbar |
- Lot codes and dates
11 of 11 products
Products covered by this recall Model / number Product as published 03613720245681B15130607S, , Lot Numbers: 19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479 03613720245674B15130609S, , Lot Numbers: 18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734 03613720193760B15130611S, , Lot Numbers: 19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732 03613720193784B15130613S, , Lot Numbers: 18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909 03613720193807B15130615S, , Lot Numbers: 20I0097 03613720275572B15900806, , Lot Numbers: 19A0329R 03613720275589B15900906, , Lot Numbers: 19A0340R 03613720275596B15901006, , Lot Numbers: 19A0339R 03613720275602B15901106, , Lot Numbers: 19A0338R, 19G0337 03613720275619B15901206, , Lot Numbers: 19A0337R 03613720275626B15901306, , Lot Numbers: 19A0336R - Amount recalled
- 730 units
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Medicrea International recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.