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. 10N47502, 10N55002, 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 Dual Thread Screw-In Anchor is a medical device used in various surgical procedures to secure sutures and other materials. Consumers typically purchase these anchors for their reliability in medical settings.
Why This Is Dangerous
The reported failures include breakage and pull-out of the anchors, which can lead to serious complications during surgical procedures. This jeopardizes patient safety and can result in additional medical interventions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face potential safety risks due to the device failures. Immediate action is required to prevent complications associated with using the recalled anchors.
Practical Guidance
How to identify if yours is affected
- Check the model numbers on your device for 10N47502 or 10N55002.
- Verify that the product is part of the recall by consulting the manufacturer's notification.
- Confirm the UDI code against the recalled list if available.
Where to find product info
Model numbers and UDI codes are typically found on the product packaging or the device itself.
What timeline to expect
Expect processing for refunds or replacements to take 4-6 weeks after the return of the product.
If the manufacturer is unresponsive
- Contact Aju Pharm again using the provided channels.
- Document all correspondence and attempts to reach out for a resolution.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Only purchase medical devices from reputable manufacturers with strong safety records.
- Look for FDA approval or clearance on medical devices before use.
- Consult healthcare professionals regarding the safety of devices used in medical procedures.
Documentation advice
Keep a record of all communications regarding the recall, including emails, letters, and phone call notes.
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Product Details
The recalled products include Genesis Dual Thread Screw-In Anchors, Model No. 10N47502 and 10N55002. The devices were distributed nationwide in the United States, particularly in California and Puerto Rico. The quantity recalled is 400 units.
Key Facts
- Recalled product: Genesis Dual Thread Screw-In Anchor
- Model Numbers: 10N47502, 10N55002
- Distribution: US Nationwide, California & Puerto Rico
- Recall Date: December 17, 2025
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