# FDA recall Z-2967-2018

> **Encore Medical, Lp** · Class II · device recall initiated 2018-05-14.

## Product

Foundation Modular Femoral Stem, Part Number, 220-10-110.  Knee prosthesis component.     The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.

## Reason for recall

After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.

## Distribution

U.S. Distribution to states of: AZ, MO, MS, NY, OK, and  UT; internationally to: Japan.

## Key facts

- **Recall number:** Z-2967-2018
- **Recalling firm:** Encore Medical, Lp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-14
- **Report date:** 2018-09-12
- **Termination date:** 2020-08-17

- **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-2967-2018

## Citation

> AI Analytics. FDA recall Z-2967-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2967-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*