Recall archive / FDA device enforcement
IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B... — FDA record Z-2452-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 12, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Reason
- There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
- Classification
- Class II
- Recalling firm
- Medicrea International
- Quantity
- 248 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2452-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Aug 30, 2023
- Recall initiation date
- Jul 12, 2023
- Center classification date
- Aug 24, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.