Device product
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Z-1460-2026
Product summary
- Event
- Event 98340
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 implants
- Official record key
device-enforcement:Z-1460-2026
Official wording
Reason: Knee and Humeral socket implants contain incorrect labeling.
Code information: Lot Code: Lot: 378P1382 GTIN: 00888912144544
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.
Derived failure modes
-
Labeling or packaging
incorrect labeling