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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-2453-2023
Recall Event ID 92738
510(K)Number K083798  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product IMPIX ALIF, REF numbers:
a) B15111209,
b) B15111212,
c) B15111409,
d) B15111412; intervertebral fusion device - lumbar
Code Information a) B15111209, GTIN 03613720193395, Lot Numbers: 19C0772; b) B15111212, GTIN 03613720193401, Lot Numbers: 19C0775, 19G0070; c) B15111409, GTIN 03613720193425, Lot Numbers: 19E0353; d) B15111412, GTIN 03613720193432, Lot Numbers: 19C0788
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 11 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 = MAX and Original Applicant = MEDICREA TECHNOLOGIES
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