FDA-Device2026-03-04Class II
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Encore Medical, LP
Hazard
Knee and Humeral socket implants contain incorrect labeling.
Sold states
US Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, CA.
Affected count
20 implants
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1460-2026Original summary
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036 Knee and Humeral socket implants contain incorrect labeling. Lot Code: Lot: 378P1382 GTIN: 00888912144544 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. Affected quantity: 20 implants
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