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FDA-Device2026-02-11Class IIPACKAGING DEFECT

Encore Medical EMPOWR Acetabular System liners recalled for packaging mismatch

Encore Medical
LABEL MIX UPALCAIAMAMIMOMSNJNYOKPARITX

Check Encore Medical hip implant liner packaging

Encore Medical discovered that some packages of EMPOWR Acetabular System hip implant liners contained the wrong device inside—for example, a box labeled as one size contained a different size. This packaging error could force surgeons to delay surgery or perform additional procedures to swap out the correct implant.

  • If you work at a hospital or surgical facility, locate any EMPOWR Acetabular System liners (ref 942-01-36H, 942-01-36J, 942-01-40G, or 942-01-32C) with expiration 03-15-2026
  • Open and verify the contents match the package label before surgery
  • Contact Encore Medical or your distributor if contents do not match the label
  • Do not use a mismatched device; return it to Encore Medical
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
49
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2026

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