# FDA recall Z-0480-2021

> **Encore Medical, LP** · Class II · device recall initiated 2020-06-19.

## Product

EMPOWR Partial Knee Peg Drill; Model: 800-06-008.

## Reason for recall

There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a potential of a delay in surgery if this issue were to recur.

## Distribution

US: AZ, CA, FL, GA, IL,  IN,  MI, MN, NY, TX, VA, and WA..  No OUS Consignees.

## Key facts

- **Recall number:** Z-0480-2021
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-19
- **Report date:** 2020-12-02

- **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-0480-2021

## Citation

> AI Analytics. FDA recall Z-0480-2021. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0480-2021. Source: US FDA. Licensed CC0.

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