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
- Screw-In Anchor
- Model numbers
- Model No. 10B45003, 10B55003, 10B65003, 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 Genesis Screw-In Anchor is a medical device used to secure various medical applications. Users typically include healthcare providers and patients requiring secure anchoring for surgical or medical procedures.
Why This Is Dangerous
Device failure can result in anchors breaking or pulling out, which poses a risk to patient safety. Suture breakage may also lead to complications in medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers may face urgent safety concerns and the need for immediate replacement, which could disrupt medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number on the product packaging.
- Look for UDI codes on the device.
- Verify if you purchased the product from California or Puerto Rico.
Where to find product info
Model numbers and UDI codes can typically be found on the product's packaging or user manual.
What timeline to expect
Expect 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Contact Aju Pharm Co., Ltd. directly for assistance.
- Document all correspondence and attempts to resolve the issue.
How to prevent similar issues
- Always check for recalls before purchasing medical devices.
- Look for safety certifications and quality assurance marks on medical products.
- Consult healthcare professionals for recommendations on reliable products.
Documentation advice
Keep records of your purchase, any communication with the manufacturer, and photos of the product as evidence.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled products include Genesis Screw-In Anchors, Model No. 10B45003, 10B55003, and 10B65003. These anchors were distributed nationwide in the United States, specifically in California and Puerto Rico.
Key Facts
- Distributed in California and Puerto Rico
- High hazard level due to device failure
- Immediate stop-use action required
- Contact Aju Pharm for guidance
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.