EMPOWR Acetabular System — Class II medical device recall Z-1929-2020
Ongoing recall by Encore Medical, LP, reported 2020-05-20, distributed nationwide. The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impacti
| Recall number | Z-1929-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2019-10-22 |
| Classified | 2020-05-08 |
| Reported by FDA | 2020-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 86 units |
| Reason classes | packaging |
| Model numbers | 803-15-023, 803-15-026, 803-15-027, 803-15-028, 803-15-029, 803-15-030 |
Product
EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head; rheumatoid arthritis, correction of functional deformity, femoral fracture, and in the salvage of previously failed surgical attempts.
Reason for recall
The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
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-1929-2020. 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.