# FDA recall Z-0041-2018

> **Encore Medical, Lp** · Class II · device recall initiated 2017-09-15.

## Product

EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE      Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

## Reason for recall

It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0041-2018
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-09-15
- **Report date:** 2017-11-01
- **Termination date:** 2023-08-29

- **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-0041-2018

## Citation

> AI Analytics. FDA recall Z-0041-2018. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0041-2018. Source: US FDA. Licensed CC0.

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