Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1234-2026

January 05, 2026

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 98177
Status
Ongoing
Classification
Class II
Quantity
49
Official record key
device-enforcement:Z-1234-2026

Official wording

Reason: 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.

Code information: 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)

Distribution pattern: US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.