Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
FDA device recall Z-1039-2026 · posted 2026-01-09 · Open, Classified
Recall details
- Recalling firm
- Medicrea International
- Reason for recall
- Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
- Action taken
- 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
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MAX
- Quantity affected
- 44 units
- Distribution
- US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
- Date initiated
- 2025-10-29
- Date posted
- 2026-01-09
- Location
- Vancia Rillieux La Pape, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IB3D™ PL Spinal System (K241164) | Medicrea International S.A.S. (Medtronic) | 2024-09-06 |