FDARecall

[Recall] — Brand Name: Reverse Shoulder P — Knee and Humeral socket implants contain

Feb 24, 2026

Published: 2026-02-24Captured: 2026-03-01Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036Product Code: PHX

FDA device recall (Open, Classified). : Knee and Humeral socket implants contain incorrect labeling..

•Status: Open, Classified
•Root cause: Process control
•Action: On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansi...
•Related 510(k): K051075

Reason:Knee and Humeral socket implants contain incorrect labeling.

Root Cause:Process control

Action

On January 16, 2026 Enovis (Encore Medical, L.P.) issued an Urgent: Medical Device Recall Expansion notification via E-Mail. The expansion was conducted to include additional products. The original...

Status:Open, Classified

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.

Related 510(k):K051075

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