Genesis Knotless Anchor Recall: Anchor Breakage 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 Genesis Knotless Anchor devices after reports of anchor breakage, bending, pull-out, and suture failure. This could lead to complications during medical procedures if the device fails.

Why it’s dangerous

The anchor can break, bend, or pull out during use, which may cause sutures to fail. This could lead to complications in surgical procedures if the device does not hold properly.

Who’s affected

Medical professionals using the Genesis Knotless Anchor for surgical procedures are most at risk. Patients undergoing surgery with this device may experience complications if the anchor fails.

How to tell if you have this one

Check for model numbers 10KPN4751 or 10KPN5501 on the device. All units with UDI codes and lots are affected.

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 10KPN4751 or 10KPN5501 on the device.
Contact Manufacturer
Reach out to Aju Pharm for further assistance if you have the affected device.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The recall reports device failures, so it is not recommended for use until the manufacturer confirms a fix.

What should I do if I have this device?

Check the model number and contact Aju Pharm for guidance on next steps.

Are there any specific risks for patients?

Patients undergoing surgery with this device may face complications if the anchor fails during the procedure.

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-1170-2026 — Aju Pharm Aju Pharm

Hello,

I own a Aju Pharm that is covered by recall Z-1170-2026 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-1170-2026 (December 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1170-2026 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 Knotless Anchor

Use caution until it’s fixed