CLASS II ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report
Impix 3D recalled by Medicrea International
Medicrea International is recalling Impix 3D, distributed nationwide in the US. The recall was initiated on 12 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2452-2023
- FDA event ID
- 92738
- Recalling firm
- Medicrea International, Rillieux La Pape, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jul 2023
- FDA classified
- 24 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Spinal Implants
Timeline
| 12 Jul 2023 | Recall initiated by company | |
| 24 Aug 2023 | Classified by FDA | +43 days |
| 30 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m) B247C07062410, n) B247C07062810, o) B247C07063210, p) B247C08062410, q) B247C08062810, r) B247C08063210, s) B247C09062410, t) B247C09062810, u) B247C09063210, v) B247C10062410, w) B247C10062810, x) B247C10063210, y) B247C11062410, z) B247C11062810, aa) B247C11063210, bb) B247C12062410, cc) B247C12062810, dd) B247C12063210, ee) B247C13062410, ff) B247C13062810, gg) B247C13063210, hh) B247C14062410, ii) B247C14062810, jj) B247C14063210, kk) B247C15062810, ll) B247C15063210; intervertebral fusion device - lumbar
Where it was distributed
US nationwide
Questions about this recall
Why was it recalled?
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Which lots are affected?
a) B242C09122810, GTIN 03613720284444, Lot Numbers: 20B0926, 20B0984; b) B242C10062810, GTIN 03613720270522, Lot Numbers: 18E0499; c) B242C10122810, GTIN 03613720284451, Lot Numbers: 20B0928, 20B0985; d) B242C11062810, GTIN 03613720270539, Lot Numbers: 18D0708, 19F0261; e) B242C11122810, GTIN 03613720284468, Lot Numbers: 20B0930, 20B0986; f) B242C12062810, GTIN 03613720270546, Lot Numbers: 18D0709, 19G0038; g) B242C12122810, GTIN 03613720284475, Lot Numbers: 20B0931, 20B0987; h) B242C12123310, GTIN 03613720284543, Lot Numbers: 20C0374; i) B242C13062810, GTIN 03613720270553, Lot Numbers: 18D0710, 19F0263; j) B242C13122810, GTIN 03613720284482, Lot Numbers: 20E0343; k) B242C14122810, GTIN 03613720284499, Lot Numbers: 20B0932; l) B242C15122810, GTIN 03613720284505, Lot Numbers: 20B0933; m) B247C07062410, GTIN 03613720272762, Lot Numbers: 18D0965, 18I0576, 18L0085; n) B247C07062810, GTIN 03613720272779, Lot Numbers: 18I0577, 18L0084; o) B247C07063210, GTIN 03613720272786, Lot Numbers: 18I0492; p) B247C08062410, GTIN 03613720272533, Lot Numbers: 18D0966, 18I0579, 18L0086; q) B247C08062810, GTIN 03613720272526, Lot Numbers: 18I0554, 18I0580; r) B247C08063210, GTIN 03613720272540, Lot Numbers: 18I0493; s) B247C09062410, GTIN 03613720272557, Lot Numbers: 18D0967, 18I0582, 18L0088, 19F0264; t) B247C09062810, GTIN 03613720272564, Lot Numbers: 18H0611R, 18H0611R/1, 18I0555; u) B247C09063210, GTIN 03613720272571, Lot Numbers: 18I0494; v) B247C10062410, GTIN 03613720272588, Lot Numbers: 18D0968, 18I0584, 18L0089, 20A0451; w) B247C10062810, GTIN 03613720272595, Lot Numbers: 18H0612, 18H0612/1, 18H0612/2; x) B247C10063210, GTIN 03613720272601, Lot Numbers: 18I0495; y) B247C11062410, GTIN 03613720272618, Lot Numbers: 18D0969, 18I0586, 19F0265; z) B247C11062810, GTIN 03613720272625, Lot Numbers: 18H0613, 18H0613/1; aa) B247C11063210, GTIN 03613720272632, Lot Numbers: 18I0496; bb) B247C12062410, GTIN 03613720272649, Lot Numbers: 18D0970; cc) B247C12062810, GTIN 03613720272656, Lot Numbers: 18H0614, 18I0558; dd) B247C12063210, GTIN 03613720272663, Lot Numbers: 18I0560; ee) B247C13062410, GTIN 03613720272670, Lot Numbers: 18I0589; ff) B247C13062810, GTIN 03613720272687, Lot Numbers: 18H0615; gg) B247C13063210, GTIN 03613720272694, Lot Numbers: 18I0561; hh) B247C14062410, GTIN 03613720272700, Lot Numbers: 18L0099; ii) B247C14062810, GTIN 03613720272717, Lot Numbers: 18H0616/1/1, 18H0616/2; jj) B247C14063210, GTIN 03613720272724, Lot Numbers: 18I0562; kk) B247C15062810, GTIN 03613720272748, Lot Numbers: 18I0498; ll) B247C15063210, GTIN 03613720272755, Lot Numbers: 18I0563
Where was it sold?
US nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 92738This product is part of a recall event; the main page for the event is Impix S recalled by Medicrea International.
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