Medicrea International: 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

Recall number

Z-2452-2023

Recalling firm

Medicrea International

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

Status

Open, Classified

Initiated

2023-07-12

Posted

2023-08-24

Terminated

not on file

Reason

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.

Root cause

Under Investigation by firm

Action

Beginning 12 July 2023, In the U.S. Medtronic disseminated an URGENT: MEDICAL PRODUCT RECALL to its consignees via UPS 2-Day delivery. The notice explained the problem, risk, and requested the following: Medtronic requests that you immediately take the following actions: Identify and quarantine any unused impacted product(s). Return all unused and non-expired product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.

Quantity

248 units

Distribution

US nationwide

Lot, serial or model codes

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

510(k) numbers

["K163595"]

PMA numbers

not on file

Product code

MAX

Firm FEI

1000432246

Firm city

Vancia Vancia Rillieux La Pape

Firm state

not on file

Firm country

France

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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