Reported Aug 30, 2023 · Ongoing

IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, 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 C+
  • REF numbers
    • a) B20240104
    • b) B20240105
    • c) B20240106
    • d) B20240107
    • e) B20240205
    • f) B20240206
    • g) B20240207
    • h) B20240208
    • intervertebral fusion device - cervical
Lot codes and dates

8 of 8 products

Products covered by this recall
Model / numberProduct as published
03613720234241B20240104, , Lot Numbers: 19A0773, 19B0524, 19C0511, 19E0477, 19K0180
03613720234258B20240105, , Lot Numbers: 18K0653, 18L0497, 19A0636, 19A0654, 19B0189, 19C0512, 19C0664, 19I0849, 19L0701, 20G0851, 20H0262, 20I0570, 20I0877, 21D0764
03613720234265B20240106, , Lot Numbers: 18C0676R, 18C0677, 18D0172, 19E0573, 19K0687, 20B0586, 20H0263, 20J0077, 21D0148, 21J0504, 22B0181
03613720234272B20240107, , Lot Numbers: 18D0174, 18L0401, 18L0498, 19D0672, 19E0087, 19G1092, 19K0478, 20B0587, 20H0264, 21H0507, 22B0485
03613720234319B20240205, , Lot Numbers: 22D0384, 22G0443
03613720234326B20240206, , Lot Numbers: 20H0265, 22B0182
03613720234333B20240207, , Lot Numbers: 18I0761, 18J0489, 19C0513, 20A0488, 20H0266
03613720234340B20240208, , Lot Numbers: 18K0298, 19D0565, 19I0617, 20C0164, 20H0267, 22A0736
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, 7:37 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.