# FDA recall Z-0135-2021

> **Encore Medical, LP** · Class II · device recall initiated 2020-09-09.

## Product

EMPOWR Acetabular System *** EMPOWR Acetabular Cup,  Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated  REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.

## Reason for recall

Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.

## Distribution

U.S. Nationwide distribution including in the states of CA, MN, MS, NY, SC, TN and VA.

## Key facts

- **Recall number:** Z-0135-2021
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-09-09
- **Report date:** 2020-10-28

- **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-0135-2021

## Citation

> AI Analytics. FDA recall Z-0135-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0135-2021. Source: US FDA. Licensed CC0.

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