Encore Medical, LP recalls Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT

Knee and Humeral socket implants contain incorrect labeling.

On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansion notification via E-Mail. The expansion was conducted to include additional products. The original notice was issued on July 9, 2025 Enovis is asking consignees to take the following actions 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.

• FDA enforcement recordOfficial FDA database entry for Z-1458-2026
• FDA 510(k) clearance · K100741The device's official FDA premarket clearance record
• FDA device classification · KWSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3660The 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.