Class 2 Device Recall RSP Humeral Socket Insert

• Date Initiated by Firm: January 15, 2026
• Date Posted: February 24, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1458-2026
• Recall Event ID: 98340
• 510(K)Number: K100741
• Product Classification: Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
• Product: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
• Code Information: Lot Code: Lot: 385P1263 GTIN: 00888912144575
• FEI Number: 1000116912
• Recalling Firm/ Manufacturer: Encore Medical, LP; 9800 Metric Blvd; Austin TX 78758-5445
• For Additional Information Contact: Sherri Mellingen; 952-9136383
• Manufacturer Reason for Recall: Knee and Humeral socket implants contain incorrect labeling.
• FDA Determined Cause: Process control
• Action: 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.
• Quantity in Commerce: 20 implants
• Distribution: US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KWS