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) B15328071S
    • b) B15328073S
    • c) B15328074S
    • d) B15334072S
    • e) B15334073S
    • f) B15334074S
    • intervertebral fusion device - cervical
Lot codes and dates

6 of 6 products

Products covered by this recall
Model / numberProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.