Fixone Hybrid Anchor Recall: Anchor Failure Risk

Take action

Contact the company & request your remedy

Recalling firmAju Pharm Co., Ltd.Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang · Seongnam, N/A N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Aju Pharm is recalling Fixone Hybrid Anchor devices because reports show anchors can break, bend, pull out, or cause sutures to break. This could lead to injury if the anchor fails during use.

Why it’s dangerous

The anchor can break, bend, or pull out during use, which may cause sutures to break. This could lead to injury if the device fails while being used in medical procedures.

Who’s affected

People who own or use Fixone Hybrid Anchors for medical procedures are affected. Those using the device for surgery or medical anchoring are at higher risk.

How to tell if you have this one

Check for model numbers KAPN-47501nc, KAPN-55001c, KAPN-55001na, or KAPN-55001nc on the device. All units with UDI codes are included in this recall.

Brand
Aju Pharm
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for model numbers KAPN-47501nc, KAPN-55001c, KAPN-55001na, or KAPN-55001nc on the device.
Contact Manufacturer
Reach out to Aju Pharm for further assistance if you have the recalled device.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to reports of anchor failure, including breakage, bending, pull-out, and suture breakage.

What models are affected?

Models KAPN-475001nc, KAPN-55001c, KAPN-55001na, and KAPN-55001nc are affected.

How can I tell if my device is recalled?

Check for the model numbers listed or UDI codes on the device.

Take action

Contact Aju Pharm

We’ve drafted a message you can send Aju Pharm to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1166-2026 — Aju Pharm Aju Pharm

Hello,

I own a Aju Pharm that is covered by recall Z-1166-2026 from Aju Pharm.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1166-2026 (December 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1166-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Aju Pharm Co., Ltd. recalls Fixone Hybrid Anchor

Use caution until it’s fixed