# FDA recall Z-0326-2018

> **Encore Medical, Lp** · Class II · device recall initiated 2017-12-12.

## Product

DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE,   REF 801-05-042, NON STERILE, Qty 1  For use in orthopedic surgery.

## Reason for recall

The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.

## Distribution

One medical device distributor in California.

## Key facts

- **Recall number:** Z-0326-2018
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-12
- **Report date:** 2018-01-17
- **Termination date:** 2022-06-13

- **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-0326-2018

## Citation

> AI Analytics. FDA recall Z-0326-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0326-2018. Source: US FDA. Licensed CC0.

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