Z-1460-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 4, 2026
- Initiation Date
- January 15, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 implants
Product Description
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Reason for Recall
Knee and Humeral socket implants contain incorrect labeling.
Distribution Pattern
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Code Information
Lot Code: Lot: 378P1382 GTIN: 00888912144544