Reported Aug 30, 2023 · Ongoing

IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, 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?

  • IMPIX DLIF
  • REF numbers
    • a) B16123509
    • b) B16123511
    • c) B16124009
    • d) B16124013
    • e) B16124509
    • f) B16124511
    • g) B16124513
    • h) B16164009
    • i) B16164013
    • j) B16165009
    • k) B16165013
    • intervertebral fusion device - lumbar
Lot codes and dates

11 of 11 products

Products covered by this recall
Model / numberProduct as published
03613720196341B16123509, , Lot Numbers: 20B0490
03613720196358B16123511, , Lot Numbers: 19G0068
03613720196396B16124009, , Lot Numbers: 19K0269
03613720196419B16124013, , Lot Numbers: 19F0715
03613720196440B16124509, , Lot Numbers: 19F0713
03613720196457B16124511, , Lot Numbers: 19F0716
03613720196464B16124513, , Lot Numbers: 19K0270
03613720196495B16164009, , Lot Numbers: 18F1034
03613720196518B16164013, , Lot Numbers: 18G0178
03613720196594B16165009, , Lot Numbers: 18C0626
03613720196617B16165013, , Lot Numbers: 18C0629
Amount recalled
24 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.

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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, 4:54 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.