Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

On 12/18/2024, recall notices were emailed to consignees who were asked to do the following: 1. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2. Review your stock for the products and lot numbers for the items to be returned. 3. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. 4. Complete and return the acknowledgement and response form via email to Lesli.Helmick@enovis.com If you have questions contact the firm at productsafety@enovis.com

• FDA enforcement recordOfficial FDA database entry for Z-0766-2025
• FDA 510(k) clearance · K143242The device's official FDA premarket clearance record
• FDA device classification · JWHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Encore Medical, LPSearch 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.