# FDA recall Z-0227-2026

> **Theken Companies LLC** · Class II · device recall initiated 2025-09-11.

## Product

iNSitu Bipolar Hip System, Bipolar head implant    Part ID	Description  10-22-0038	Bipolar Head Assembly, Size 38mm  10-22-0040	Bipolar Head Assembly, Size 40mm  10-22-0042	Bipolar Head Assembly, Size 42mm  10-22-0044	Bipolar Head Assembly, Size 44mm  10-22-0046	Bipolar Head Assembly, Size 46mm  10-22-0048	Bipolar Head Assembly, Size 48mm  10-22-0050	Bipolar Head Assembly, Size 50mm  10-22-0052	Bipolar Head Assembly, Size 52mm  10-22-0054	Bipolar Head Assembly, Size 54mm  10-22-0056	Bipolar Head Assembly, Size 56mm  10-22-0058	Bipolar Head Assembly, Size 58mm  10-22-0060	Bipolar Head Assembly, Size 60mm

## Reason for recall

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

## Distribution

US Nationwide distribution in the states of NJ, PA, and TX.

## Key facts

- **Recall number:** Z-0227-2026
- **Recalling firm:** Theken Companies LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-11
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Akron, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0227-2026

## Citation

> AI Analytics. FDA recall Z-0227-2026. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0227-2026. Source: US FDA. Licensed CC0.

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