Recall Z-1458-2026— Encore Medical, LP

Name: FDA recall Z-1458-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-15

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2026-01-15. It names one FDA 510(k) clearance: K100741. 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: Knee and Humeral socket implants contain incorrect labeling..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-01-15
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K100741 — REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012Encore Medical L.P.·cleared 2010-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.