Reported Aug 30, 2023 · Ongoing
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S;…
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?
- IMPIX S
- REF numbers
a) B15328071Sb) B15328073Sc) B15328074Sd) B15334072Se) B15334073Sf) B15334074Sintervertebral fusion device - cervical
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 03613720195535B15328071S, , Lot Numbers: 19I0696, 20A0759 03613720195573B15328073S, , Lot Numbers: 20B0747 03613720195597B15328074S, , Lot Numbers: 19I0698 03613720195832B15334072S, , Lot Numbers: 19I0557, 20F0185 03613720195856B15334073S, , Lot Numbers: 19J0947 03613720195870B15334074S, , Lot Numbers: 19E0502, 19J0091, 20F0184 - Amount recalled
- 0 (US)
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.
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