# FDA recall Z-1233-2026

> **Encore Medical, LP** · Class II · device recall initiated 2026-01-05.

## Product

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

## Reason for recall

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a  packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

## Distribution

US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

## Key facts

- **Recall number:** Z-1233-2026
- **Recalling firm:** Encore Medical, LP
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-05
- **Report date:** 2026-02-11

- **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-1233-2026

## Citation

> AI Analytics. FDA recall Z-1233-2026. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1233-2026. Source: US FDA. Licensed CC0.

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