FDA-Device2026-03-04Class IIMISBRANDING
Encore Medical reverse shoulder prosthesis recalled for incorrect labeling
LABEL MIX UPNationwide distribution
Check your Encore Medical shoulder implant labeling
Encore Medical's RSP Standard Humeral Socket Insert (36mm, HXe-plus model) was distributed with incorrect labeling. About 20 implants from a single lot were affected across multiple states. No injuries have been reported so far.
- If you received this implant (Lot 378P1382), contact your surgeon or healthcare provider immediately
- Verify the implant labeling matches the documentation in your medical records
- Keep your lot number and product information available for your provider
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-1460-2026Don't want to check this manually?
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