# FDA recall Z-0432-2026

> **Total Joint Orthopedics, Inc.** · Class II · device recall initiated 2025-09-23.

## Product

Brand Name: Klassic BiPolar Head    Model/Catalog Number:   3205.41.022	Klassic BiPolar Head, 41 mm OD, 22 mm Head;  3205.42.022	Klassic BiPolar Head, 42 mm OD, 22 mm Head;  3205.43.022	Klassic BiPolar Head, 43 mm OD, 22 mm Head;  3205.44.028	Klassic BiPolar Head, 44 mm OD, 28 mm Head;  3205.45.028	Klassic BiPolar Head, 45 mm OD, 28 mm Head;  3205.46.028	Klassic BiPolar Head, 46 mm OD, 28 mm Head;  3205.47.028	Klassic BiPolar Head, 47 mm OD, 28 mm Head;  3205.48.028	Klassic BiPolar Head, 48 mm OD, 28 mm Head;  3205.49.028	Klassic BiPolar Head, 49 mm OD, 28 mm Head;  3205.50.028	Klassic BiPolar Head, 50 mm OD, 28 mm Head;  3205.51.028	Klassic BiPolar Head, 51 mm OD, 28 mm Head;  3205.52.028	Klassic BiPolar Head, 52 mm OD, 28 mm Head;  3205.53.028	Klassic BiPolar Head, 53 mm OD, 28 mm Head;  3205.54.028	Klassic BiPolar Head, 54 mm OD, 28 mm Head;  3205.55.028	Klassic BiPolar Head, 55 mm OD, 28 mm Head;  3205.56.028	Klassic BiPolar Head, 56 mm OD, 28 mm Head;  3205.58.028	Klassic BiPolar 

## Reason for recall

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

## Distribution

US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.

## Key facts

- **Recall number:** Z-0432-2026
- **Recalling firm:** Total Joint Orthopedics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-23
- **Report date:** 2025-11-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0432-2026

## Citation

> AI Analytics. FDA recall Z-0432-2026. Retrieved 2026-07-31 from https://api.ai-analytics.org/recall/Z-0432-2026. Source: US FDA. Licensed CC0.

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