Medshape, INC. recalls Medshape Universal Joints

Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

On 6/2/2025, recall notice were emailed to consignees who were asked to do the following: 1) Review your stock for the products and lot numbers for the items to be returned. 2) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3) Complete acknowledgement and response form and return via email to FAsalessupport@enovis.com If you have any questions, contact firm at productsafety@enovis.com

• FDA enforcement recordOfficial FDA database entry for Z-2513-2025
• FDA 510(k) clearance · K151580The device's official FDA premarket clearance record
• FDA device classification · KTTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3030The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medshape, INC.Search 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.