Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, ...
FDA Recall #Z-1460-2026 — Class II — January 15, 2026
Product Description
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
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: 378P1382 GTIN: 00888912144544
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated