Medicrea, IB3D Universal Implant Inserter, Rx Only recallZ-1038-2026 · Medicrea International · initiated Oct 29, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medicrea International or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-1038-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 29, 2025
- Posted by the FDA
- Jan 9, 2026
- Recalling firm
- Medicrea International
- Quantity
- 44 units
- Product code
- MAX
- FDA submissions
- K241164
- Distribution
- US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Product description
Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
Code information (models, lots, serial numbers)
Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IB3D™ PL Spinal System A24000000Medicrea International · Intervertebral fusion device with bone graft, lumbar1 recall11 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 97996).
- Z-1039-2026 · Open, ClassifiedMedicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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