Aju Pharm Genesis Dual Thread Screw-In Anchor Recall: Risk of Anchor Breakage

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 Genesis Dual Thread Screw-In Anchors because they have reported failures like anchor breakage, bending, and suture breakage. This could lead to the device not working properly or causing injury.

Why it’s dangerous

The device can break, bend, or pull out during use, which may cause sutures to break. This could lead to the anchor failing in medical procedures, potentially causing injury.

Who’s affected

Users of the Genesis Dual Thread Screw-In Anchor are affected, particularly those using it for medical procedures. Those with the specific model numbers or UDI codes are most at risk.

How to tell if you have this one

Check for model numbers 10N47502 or 10N55002 on the product. All units with UDI codes and lots are included in this recall.

Brand
Aju Pharm
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number (10N47502 or 10N55002) and UDI code on the device.

✎ GovInfoNow

Questions people ask

What is the specific model number for this recall?

The model numbers are 10N47502 and 10N55002.

Is there a fix for this issue?

The recall does not mention a fix or remedy.

How can I tell if my product is affected?

Check for model numbers 10N47502 or 10N55002 and all 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-1169-2026 — Aju Pharm Aju Pharm

Hello,

I own a Aju Pharm that is covered by recall Z-1169-2026 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-1169-2026 (December 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1169-2026 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 Genesis Dual Thread Screw-In Anchor

Lower-risk recall