FDA Enforcement
Class II
Ongoing
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Recall: Z-1458-2026
·
Reported March 4, 2026
Enforcement
- Recall Number
- Z-1458-2026
- Event ID
- 98340
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Encore Medical, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 4, 2026
- Initiation Date
- January 15, 2026
- Classification Date
- February 24, 2026
- Address
- 9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States
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
Knee and Humeral socket implants contain incorrect labeling.
Code Info
Lot Code: Lot: 385P1263 GTIN: 00888912144575
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.
Quantity
20 implants