Quick Facts at a Glance
- Recall Date
- December 17, 2025
- Hazard Level
- HIGH
- Brand
- Aju Pharm Co.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Aju Pharm Co.
- Product type
- Surgical Anchor
- Model numbers
- Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc, All UDI Codes, All Lots.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 17, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aju Pharm Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Fixone Hybrid Anchor is a surgical device used in various medical procedures to secure tissues. Healthcare providers rely on its reliability during surgeries. Failures can significantly impact patient outcomes.
Why This Is Dangerous
Device failures like anchor breakage and pull-out can compromise surgical procedures, posing serious risks to patients. Such failures can lead to complications and potential injuries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers who must stop using the device, leading to potential delays in procedures and impacts on patient care.
Practical Guidance
How to identify if yours is affected
- Check if you possess any of the listed model numbers.
- Verify the device against the UDI codes provided in the recall notice.
- Consult your healthcare provider for specific guidance on the affected devices.
Where to find product info
Look for model numbers and UDI codes printed on the device packaging or the device itself.
What timeline to expect
Expect 4-6 weeks for refund or replacement processing after contacting the manufacturer.
If the manufacturer is unresponsive
- Reach out to the FDA for guidance on how to proceed.
- Document your attempts to contact the company for your records.
How to prevent similar issues
- Research device safety ratings before purchase.
- Check for recalls or safety notices before using medical devices.
- Consult with healthcare professionals about device reliability.
Documentation advice
Keep all correspondence with the manufacturer, including emails and letters, along with any receipts or records of usage.
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Product Details
The recalled products include Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, and KAPN-55001nc, along with all UDI codes and lots. These devices were distributed nationwide in the United States, specifically in California and Puerto Rico. Each unit was sold in quantities of 233.
Key Facts
- Device failures include anchor breakage and bending
- Patients should stop using the device immediately
- Contact Aju Pharm Co. for further instructions
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