# FDA recall Z-0611-2020

> **Encore Medical, Lp** · Class II · device recall initiated 2019-02-04.

## Product

EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in  instrument tray FA EMP PAT TOOL KIT Part # 800-99-096

## Reason for recall

The firm has received reports/complaints concerning the  breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long term risks may include an inflammatory response, infection, and/ or pain

## Distribution

CO, WA, CA, UT, CA, TN, TX, MS, MO, AR, OK, LA, MN, IL, IN, KY, OH, MI, PA, SC, FL, PR, AL, GA, NM, AZ, NV, VA, RI, MD, ME PA, NY  OUS: None

## Key facts

- **Recall number:** Z-0611-2020
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-02-04
- **Report date:** 2019-12-18

- **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-0611-2020

## Citation

> AI Analytics. FDA recall Z-0611-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0611-2020. Source: US FDA. Licensed CC0.

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