FDAHealthJanuary 15, 2026
Encore Medical, LP — Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
⚠️ Knee and Humeral socket implants contain incorrect labeling.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 15, 2026
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
What's affected?
- Product
- Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
- Brand
- Encore Medical, LP
- Lot code
- Lot:
Additional details
Lot Code: Lot: 385P1263 GTIN: 00888912144575
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20 implants.
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