Medicrea International Vancia Vancia Rillieux La Pape France IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
Brand
Medicrea International Vancia Vancia Rillieux La Pape France
Lot Codes / Batch Numbers
a) B15130607S, GTIN 03613720245681, Lot Numbers: 19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479, b) B15130609S, GTIN 03613720245674, Lot Numbers: 18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734, c) B15130611S, GTIN 03613720193760, Lot Numbers: 19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732, d) B15130613S, GTIN 03613720193784, Lot Numbers: 18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909, e) B15130615S, GTIN 03613720193807, Lot Numbers: 20I0097, f) B15900806, GTIN 03613720275572, Lot Numbers: 19A0329R, g) B15900906, GTIN 03613720275589, Lot Numbers: 19A0340R, h) B15901006, GTIN 03613720275596, Lot Numbers: 19A0339R, i) B15901106, GTIN 03613720275602, Lot Numbers: 19A0338R, 19G0337, j) B15901206, GTIN 03613720275619, Lot Numbers: 19A0337R, k) B15901306, GTIN 03613720275626, Lot Numbers: 19A0336R
Products Sold
a) B15130607S, GTIN 03613720245681, Lot Numbers: 19B0894, 19C0092, 19G0921, 19G0922, 19L0045, 20B0320, 20B0477, 20B0478, 20B0479; b) B15130609S, GTIN 03613720245674, Lot Numbers: 18D1077, 19J0690, 20A0042, 20A0423, 20A1000, 20B0322, 20B0476, 20F0908, 20H0481, 20I0099, 20J0734; c) B15130611S, GTIN 03613720193760, Lot Numbers: 19B0895, 19D0071, 19E0170, 19I0695, 19J0324, 20A0228, 20B0731, 20B0732; d) B15130613S, GTIN 03613720193784, Lot Numbers: 18G0602, 18I0594, 19C0091, 19F0641, 19L0032, 20F0909; e) B15130615S, GTIN 03613720193807, Lot Numbers: 20I0097; f) B15900806, GTIN 03613720275572, Lot Numbers: 19A0329R; g) B15900906, GTIN 03613720275589, Lot Numbers: 19A0340R; h) B15901006, GTIN 03613720275596, Lot Numbers: 19A0339R; i) B15901106, GTIN 03613720275602, Lot Numbers: 19A0338R, 19G0337; j) B15901206, GTIN 03613720275619, Lot Numbers: 19A0337R; k) B15901306, GTIN 03613720275626, Lot Numbers: 19A0336R
Medicrea International Vancia Vancia Rillieux La Pape France is recalling IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130 due to There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026