Home / device / Z-1234-2026 Class II Reported 2026-02-11
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 Recalled by Encore Medical, LP
Reason for Recall 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.
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Recall Number Z-1234-2026
Classification Class II
Status Ongoing
Category device
Initiated 2026-01-05
Reported 2026-02-11
Distribution US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Code Info REF/UDI-DI/Lot(Expiration): 942-01-36H/00190446309789/624Z1032(03-15-2026), 942-01-36J/00190446309802/626Z1021(03-15-2026), 942-01-40G/00190446309826/628Z1034(03-15-2026), 942-01-32C/00190446309697/615Z1026(03-15-2026) Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer .