# FDA recall Z-1167-2026

> **Aju Pharm Co., Ltd.** · Class II · device recall initiated 2025-12-17.

## Product

Fixone Biocomposite Anchor

## Reason for recall

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

## Distribution

US Nationwide distribution in the states of CA & PR.

## Key facts

- **Recall number:** Z-1167-2026
- **Recalling firm:** Aju Pharm Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-17
- **Report date:** 2026-02-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Seongnam, N/A, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1167-2026

## Citation

> AI Analytics. FDA recall Z-1167-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1167-2026. Source: US FDA. Licensed CC0.

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