Medicrea International recalls Medicrea

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

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

• FDA enforcement recordOfficial FDA database entry for Z-1038-2026
• FDA 510(k) clearance · K241164The device's official FDA premarket clearance record
• FDA device classification · MAXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3080The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medicrea InternationalSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.