EMPOWR Acetabular System: Liner — Class II medical device recall Z-1234-2026
Ongoing recall by Encore Medical, LP, reported 2026-02-11, distributed in AL, CA, IA, MA, MI, MO, MS, NJ…. 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acet
| Recall number | Z-1234-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2026-01-05 |
| Classified | 2026-02-02 |
| Reported by FDA | 2026-02-11 |
| Distributed | AL, CA, IA, MA, MI, MO, MS, NJ, NY, OK, PA, PR, RI, TX |
| Quantity | 49 |
| UPC / GTIN / UDI-DI | 00190446309697, 00190446309789, 00190446309802, 00190446309826 |
| Model numbers | 942-01-32C, 942-01-36H, 942-01-36J, 942-01-40G |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1234-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.