# FDA recall Z-1384-2023

> **Encore Medical, LP** · Class II · device recall initiated 2023-02-28.

## Product

EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108

## Reason for recall

Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone.

## Distribution

US: TX, IN, MD, CA, KS, AL, HI, WA

## Key facts

- **Recall number:** Z-1384-2023
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-28
- **Report date:** 2023-04-19

- **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-1384-2023

## Citation

> AI Analytics. FDA recall Z-1384-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1384-2023. Source: US FDA. Licensed CC0.

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