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U.S. Department of Health and Human Services

Class 2 Device Recall MEDICREA INTERNATIONAL S.A.

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  Class 2 Device Recall MEDICREA INTERNATIONAL S.A. see related information
Date Initiated by Firm July 12, 2023
Date Posted August 24, 2023
Recall Status1 Open3, Classified
Recall Number Z-2459-2023
Recall Event ID 92738
Product Classification Prosthesis, intervertebral disc - Product Code MJO
Product GRANVIA-C, REF numbers:
a)¿¿¿¿¿ A13111427,
b)¿¿¿¿ A13112567,
c)¿¿¿¿¿ A13113456,
d)¿¿¿¿ A13131516,
e)¿¿¿¿ A13131789,
f)¿¿¿¿¿¿ A13132012,
g)¿¿¿¿¿ B13111014,
h)¿¿¿¿ B13111015,
i)¿¿¿¿¿¿ B13111016,
j)¿¿¿¿¿¿ B13111017,
k)¿¿¿¿¿ B13111025,
l)¿¿¿¿¿¿ B13111026,
m)¿¿¿ B13111027,
n)¿¿¿¿ B13111034,
o)¿¿¿¿ B13111035,
p)¿¿¿¿ B13111036; intervertebral fusion device - cervical
Code Information a)¿¿¿¿¿ A13111427, GTIN 03613720235637, Lot Numbers: 19D0379, 19J0745, 20F0921; b)¿¿¿¿ A13112567, GTIN 03613720235651, Lot Numbers: 18F0191, 19D0380; c)¿¿¿¿¿ A13113456, GTIN 03613720235668. Lot Numbers: 19C0241, 20F0929; d)¿¿¿¿ A13131516, GTIN 03613720235682, Lot Numbers: 21A0438; e)¿¿¿¿ A13131789, GTIN 03613720235699, Lot Numbers: 21D0856; f)¿¿¿¿¿¿ A13132012, GTIN 03613720235705, Lot Numbers: 21D0857; g)¿¿¿¿¿ B13111014, GTIN 03613720192602, Lot Numbers: 18J0704, 19I0437, 19L0317, 20B0743, 20H0170, 20I0346; h)¿¿¿¿ B13111015, GTIN 03613720192619, Lot Numbers: 18A0891, 18L0331, 19B0305, 19D0744, 19G0689, 19I0840, 19K0222, 20A0967, 20B0167, 20I0201, 20J0513, 21A0098,; i)¿¿¿¿¿¿ B13111016, GTIN 03613720192626, Lot Numbers: 18J0705, 19C0759, 19I0435, 19L0103, 20G0353, 20K0398, 21A0099, 21A0574, 21F0151; j)¿¿¿¿¿¿ B13111017, GTIN 03613720192633, Lot Numbers: 18J0706, 21D0097, 21I0125; k)¿¿¿¿¿ B13111025, GTIN 03613720192664, Lot Numbers: 18D0593, 19A0658, 19C0394, 19K0343, 20J0514; l)¿¿¿¿¿¿ B13111026, GTIN 03613720192671, Lot Numbers: 18J0707, 20J0516, 21I0072; m)¿¿¿ B13111027, GTIN 03613720192688, Lot Numbers: 18J0709, 21A0575, 21I0126; n)¿¿¿¿ B13111034, GTIN 03613720192718, Lot Numbers: 18B1066, 18D0594, 18E0614, 18H0671, 18K0878, 18L0389, 19A0354, 19A0377, 19D0306, 19D0307, 19D0578, 19E0387, 19J0465, 19K0068, 19L0607, 20B0744, 20G0354, 20K0399, 21A0203, 21A0732, 21F0153; o)¿¿¿¿ B13111035, GTIN 03613720192725, Lot Numbers: 18A0892, 18J0465, 18J0710, 19A0355, 19B0304, 19B0394, 19B0395, 19D0579, 19F0100R, 19J0466, 19K0069, 19L0394, 20B0745, 20C0296, 20G0355, 20I0348, 20K0434, 21A0103; p)¿¿¿¿ B13111036, GTIN 03613720192732, Lot Numbers: 18B1067, 18F1031, 18J0466, 18J0711, 18L0390, 19A0356, 19B0915, 19D0581, 19G0690, 19K0157, 19L0804, 20E0256, 20I0349, 20J0512, 21A0104
Recalling Firm/
Manufacturer		 Medicrea International
Vancia
Vancia
Rillieux La Pape France
For Additional Information Contact Medtronic Customer Service
800-962-9888
Manufacturer 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 2		 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 in Commerce O (US)
Distribution US nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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