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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-2458-2023
Recall Event ID 92738
510(K)Number K110497  
Product Classification Orthosis, spinal pedicle fixation - Product Code MNI
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
Code Information 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 03613720185628, Lot Numbers: 20E0097, 21A0076, 21B0498; k) B02317550Z, GTIN 03613720185659, Lot Numbers: 20C0294, 20H0508, 20J0283, 22B0366
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 963 units
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.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = MEDICREA INTERNATIONAL
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