FDA Medical Device Recalls (openFDA)
Medicrea International: Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- Recall number
- Z-1038-2026
- Recalling firm
- Medicrea International
- Product
- Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000
- Status
- Open, Classified
- Initiated
- 2025-10-29
- Posted
- 2026-01-09
- Terminated
- not on file
- Reason
- Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
- 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 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
- 44 units
- Distribution
- US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
- Lot, serial or model codes
- Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677
- 510(k) numbers
- ["K241164"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 1000432246
- Firm city
- Vancia Rillieux La Pape
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28