FDA-Device2026-03-04Class IIMISBRANDING
Encore Medical reverse shoulder prosthesis recalled for incorrect labeling
What this means
Encore Medical's RSP humeral socket insert (model 509-00-432, lot 385P1263) has incorrect labeling that could cause confusion during surgical implantation. This affects 20 implants distributed across multiple U.S. states. No injuries have been reported.
- If you received this implant, contact your surgeon or hospital immediately
- Verify the implant labeling matches the surgical plan before use
- Do not use the implant if labeling is unclear or inconsistent
The agency's original wording
Hazard
Knee and Humeral socket implants contain incorrect labeling.
Intended for
Adults
Illnesses reported
None reported
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 HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1458-2026Want us to check the next one for you?
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