Encore Medical EMPOWR Acetabular System liners recalled for packaging mismatch
What this means
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
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1234-2026Want us to check the next one for you?
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