Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM...
FDA Recall #Z-1458-2026 — Class II — January 15, 2026
Product Description
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Reason for Recall
Knee and Humeral socket implants contain incorrect labeling.
Recalling Firm
Encore Medical, LP — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Lot Code: Lot: 385P1263 GTIN: 00888912144575
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated