Z-1038-2026Class II

Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Name: Z-1038-2026 Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Creator: Medicrea International
Published: 2025-10-29
License: https://open.fda.gov/license/

Medicrea International / initiated 2025-10-29 / Open, Classified

FDA source

Medicrea International began a recall of Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 on 2025-10-29. FDA classified it as Class II and gives the reason as "Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1038-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-29
Posted: 2026-01-09
Recalling firm: Medicrea International
Product: Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA root cause: Under Investigation by firm
Action: On 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 [email protected]. 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 commerce: 44 units
Distribution: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Product codes and lots: Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1038-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1038-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09
Z-1039-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-09

Product code MAX

K241164Class IIIB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic) / cleared 2024-09-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)