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U.S. Department of Health and Human Services

Class 2 Device Recall Medicrea, IB3D PL Instruments Set

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 Class 2 Device Recall Medicrea, IB3D PL Instruments Setsee related information
Date Initiated by FirmOctober 29, 2025
Date PostedJanuary 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1039-2026
Recall Event ID 97996
510(K)NumberK241164 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductMedicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Code Information Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174
Recalling Firm/
Manufacturer		 Medicrea International
5389 route de Strasbourg
Vancia
Rillieux La Pape France
For Additional Information ContactChristine Stewart
04-72018787
Manufacturer Reason
for Recall		Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn October 29, 2025, Medtronic issued a Urgent: Medical Device Recall Notification via UPS. Medtronic ask consignees to take the following actions: 1. Immediately identify and quarantine the potentially affected product and instruments set identified in the table above. 2. Your local Medtronic Spine Representative will be contacting you to coordinate the return of potentially affected products and instruments sets. 3. Complete and return the Customer Confirmation Form, even if you do not have any affected product. Please complete all fields, sign the form, and email neuro.quality@medtronic.com. 4. This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. 5. If purchased from a distributor, contact your distributor directly to arrange for the return of the product to your Distributor
Quantity in Commerce44 units
DistributionUS Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MAX
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