FDA-Device2026-02-11Class IIPACKAGING DEFECT
Encore Medical EMPOWR 3D knee and acetabular implants recalled for packaging mismatch
Check Encore Medical implant packages before surgery
Encore Medical discovered that some packages of knee tibial inserts and acetabular (hip socket) system components contain the wrong device inside. This packaging error could delay surgery or require unexpected revision surgery if the mismatch is not caught beforehand.
- If you have scheduled orthopedic surgery, ask your surgeon to verify the device package contents match the label before the procedure.
- If you received one of these devices, contact Encore Medical or your surgical facility immediately with the lot number 139T1075A.
- Do not use any EMPOWR 3D devices without confirming the package contents match the label.
Hazard
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Sold states
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Affected count
19
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2026Don't want to check this manually?
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