⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Encore Medical, LP: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-0

Medical DevicesSource: FDA (device) · Date: 2026-03-04

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Encore Medical, LP
Product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Reason / hazard
Knee and Humeral socket implants contain incorrect labeling.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Recall initiated
2026-01-15
Code info
Lot Code: Lot: 378P1382 GTIN: 00888912144544
Product quantity
20 implants
Voluntary mandated
Voluntary: Firm initiated
City
Austin
State
TX
Country
United States
Event id
98340
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