# FDA recall Z-1257-2022

> **Encore Medical, LP** · Class II · device recall initiated 2022-05-05.

## Product

DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

## Reason for recall

A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert.  If implanted, a risk may include leaving debris in the joint space.

## Distribution

U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.

## Key facts

- **Recall number:** Z-1257-2022
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-05
- **Report date:** 2022-06-15

- **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-1257-2022

## Citation

> AI Analytics. FDA recall Z-1257-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1257-2022. Source: US FDA. Licensed CC0.

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