Class II

Medical Device Recall: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036

Encore Medical, LP · January 15, 2026

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.

States Affected

NATIONWIDE

Quantity Affected

20 implants

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1460-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.