Encore Medical, LP
Device Recalls (Class II)
Class II
Z-1458-2026
·
20260304
·
Ongoing
Product
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.
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.
Source: openFDA Enforcement API