Reported Aug 30, 2023 · Ongoing

IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar

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 ALIF
  • REF numbers
    • a) B15111209
    • b) B15111212
    • c) B15111409
    • d) B15111412
    • intervertebral fusion device - lumbar
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberProduct as published
03613720193395B15111209, , Lot Numbers: 19C0772
03613720193401B15111212, , Lot Numbers: 19C0775, 19G0070
03613720193425B15111409, , Lot Numbers: 19E0353
03613720193432B15111412, , Lot Numbers: 19C0788
Amount recalled
11 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.

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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, 6:54 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.