FDA-Device2026-03-04Class IIMISBRANDING
Encore Medical EMPOWR 3D Knee implants recalled for incorrect labeling
What this means
Encore Medical's EMPOWR 3D Knee implants (model 341-16-707, lot 151T1055A) were distributed with incorrect labeling that could affect proper surgical placement or identification. Fourteen implants were affected across multiple states. No injuries have been reported.
- If you received this implant, contact your surgeon or Encore Medical immediately to verify your implant's lot number and labeling
- Do not discard the implant or packaging—your surgeon will advise next steps
- Ask your surgeon to confirm the correct implant specifications for your procedure
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
14 implants
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1459-2026Want us to check the next one for you?
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