Reported Aug 30, 2023 · Ongoing
IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B20181763, 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?
13 of 13 products
| # | Product as published |
|---|---|
| 1 | A20150407 |
| 2 | A20250407 |
| 3 | A20350567 |
| 4 | B20181743 |
| 5 | B20181753 |
| 6 | B20181763 |
| 7 | B20181773 |
| 8 | B20181943 |
| 9 | B20181953 |
| 10 | B20181963 |
| 11 | B20181973 |
| 12 | B20182253 |
| 13 | B20182263; intervertebral fusion device - lumbar |
- Lot codes and dates
13 of 13 products
Products covered by this recall Model / number Product as published 03613720236016A20150407, , Lot Numbers: 18F0803, 18J0713, 18J0714, 19A0225, 19A0786, 19A0787, 19D0381, 19D0382, 19J0594, 20A0280, 20H0285, 20I0475, 20K0424, 21D0442, 21I0596, 22E0637 03613720236078A20250407, , Lot Numbers: 18E0532, 18I0840, 18I0841, 18K0067, 18K0068, 18L0399, 19A0371, 19A0372, 19C0587, 19D0383, 19D0384, 19J0592, 19J0746, 19K0731, 19K0853, 20A0281, 20C0260, 20F0920, 20H0286, 20I0476, 20J0558, 20K0425, 21D0858, 21F0990, 21I0598, 22C0262, 22C0268, 22D0732, 22E0638, 22E0640, 22E0642, 22E0656, 22F0408, 22F0409 03613720236108A20350567, , Lot Numbers: 18K0069, 19B0752, 19D0745, 20A0279, 20F0922, 20I0477, 21D0443, 21G0784, 22D0733, 22G0683 03613720233251B20181743, , Lot Numbers: 19D0208, 19E0604, 19K0588 03613720233275B20181753, , Lot Numbers: 20G0209, 20I0486, 20L0199, 21C0843 03613720233305B20181763, , Lot Numbers: 18L0570, 19D0100, 19G0205, 19J0470, 20A0645 03613720233336B20181773, , Lot Numbers: 19A0830, 19J0611, 19L0612, 20I0831 03613720233442B20181943, , Lot Numbers: 19K0878, 20E0094, 21G0420 03613720233466B20181953, , Lot Numbers: 21K0501 03613720233497B20181963, , Lot Numbers: 21K0502 03613720233527B20181973, , Lot Numbers: 21C0844 03613720233657B20182253, , Lot Numbers: 19J0471, 19J0711, 20I0832 03613720233688B20182263, , Lot Numbers: 22D0811 - Amount recalled
- 4489 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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