Class IIReported 2026-03-04

Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432

Recalled by Encore Medical, LP

Reason for Recall

Knee and Humeral socket implants contain incorrect labeling.

Recall Number

Z-1458-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-15

Reported

2026-03-04

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 Info

Lot Code: Lot: 385P1263 GTIN: 00888912144575

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.