Fixone Biocomposite Anchor
Reported: February 4, 2026 Initiated: December 17, 2025 #Z-1167-2026
Product Description
Fixone Biocomposite Anchor
Reason for Recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Details
- Recalling Firm
- Aju Pharm Co., Ltd.
- Units Affected
- 1,088 units
- Distribution
- US Nationwide distribution in the states of CA & PR.
- Location
- Seongnam, N/A
Frequently Asked Questions
What product was recalled? ▼
Fixone Biocomposite Anchor. Recalled by Aju Pharm Co., Ltd.. Units affected: 1,088 units.
Why was this product recalled? ▼
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2026. Severity: Moderate. Recall number: Z-1167-2026.
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