Recall Z-2458-2023

Medicrea International · initiated July 12, 2023

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical

Codes / lots: a) B02315535Z, GTIN 03613720185086, Lot Numbers: 21J0184; b) B02315540Z, GTIN 03613720185116, Lot Numbers: 18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616; c) B02315545Z, GTIN 03613720185147, Lot Numbers: 18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147; d) B02315550Z, GTIN 03613720185178, Lot Numbers: 19E0306, 20F0009; e) B02316535Z, GTIN 03613720185321, Lot Numbers: 21J0185, 21J0899; f) B02316540Z, GTIN 03613720185352, Lot Numbers: 18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339; g) B02316545Z, GTIN 03613720185383, Lot Numbers: 18D1035, 18E0508, 18F0534, 18G0170, 18G0591, 18H0588, 18J0054, 18K0279, 18K0865, 19A0066, 19B0093, 19B0912, 19C0138, 19D0177, 19E0084, 19G0188, 19J0227, 19J0228, 19K0764, 19L0360, 19L0580, 20B0688, 20H0151, 20J0415, 20L0238, 21A0109, 21A0642, 21D0174, 21F0505, 21L0394, 22A0047, 22L0091; h) B02316550Z, GTIN 03613720185413, Lot Numbers: 21A0506, 21C0501; i) B02317540Z, GTIN 03613720185598, Lot Numbers: 21A0110, 21A0508, 21A0524, 22B0782; j) B02317545Z, GTIN…

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.

FDA-determined cause: Under Investigation by firm

Action taken

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.

Details

Recall number
Z-2458-2023
Initiated
July 12, 2023
Posted by FDA
August 24, 2023
Product code
MNI – Orthosis, Spinal Pedicle Fixation
Quantity
963 units
Distribution
US nationwide
Recalling firm
Medicrea International, Vancia Vancia Rillieux La Pape

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2452-2023 Class IIIMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2453-2023 Class IIIMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2454-2023 Class IIIMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbarThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2455-2023 Class IIIMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2456-2023 Class IIIMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2457-2023 Class IIIMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2459-2023 Class IIGRANVIA-C, REF numbers: a) A13111427, b) A13112567, c) A13113456, d) A13131516, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2460-2023 Class IIIMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2461-2023 Class IIIMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified
Z-2462-2023 Class IIIMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e)…There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the… 07/12/2023Open, Classified