# FDA recall Z-0060-2021

> **Encore Medical, LP** · Class II · device recall initiated 2020-08-03.

## Product

DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee  - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.

## Reason for recall

There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting.  If  undetected, there is a potential of leaving debris in the joint space.

## Distribution

U.S. Nationwide distribution including in the states of VA, TN, MN, TX, IL, IN, KY, OH, SC, RI, MD, PA, NY, CA, KS, OK, AR, LA, FL, AL, GA, AZ, NV, WA, MS, ME, NV and Puerto Rico.

## Key facts

- **Recall number:** Z-0060-2021
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-08-03
- **Report date:** 2020-10-14

- **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-0060-2021

## Citation

> AI Analytics. FDA recall Z-0060-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0060-2021. Source: US FDA. Licensed CC0.

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