# FDA recall Z-1929-2020

> **Encore Medical, LP** · Class II · device recall initiated 2019-10-22.

## 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.

## Distribution

US Nationwide distribution including in the states of MN, VA, IL, IN, SC, N, TX, CA.

## Key facts

- **Recall number:** Z-1929-2020
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-22
- **Report date:** 2020-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Austin, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1929-2020

## Citation

> AI Analytics. FDA recall Z-1929-2020. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-1929-2020. Source: US FDA. Licensed CC0.

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