Encore Medical, LP recalls Brand Name: Reverse Shoulder Prosthesis
- Recalling company
- Encore Medical, LP
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 15, 2026
- Reported
- Mar 4, 2026
- 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.
- Status
- Ongoing
- Quantity
- 20 implants
- Lot / codes
- Lot Code: Lot: 385P1263 GTIN: 00888912144575
- Company location
- Austin, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1458-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1458-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.