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. 20BN4753, 20BN5503, 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 AlternatiV+ Screw-In Anchor is a medical device used for various surgical applications. It allows for secure attachment during medical procedures, making it crucial for patient safety.
Why This Is Dangerous
The reported failures of the anchor can lead to inadequate securement during surgical procedures, posing significant health risks. Such failures can compromise the effectiveness of the surgery and result in additional medical complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this device may face serious health risks, necessitating immediate action to cease use and consult healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check the model numbers: 20BN4753 and 20BN5503.
- Refer to any packaging or documentation associated with the device.
- Contact your healthcare provider for assistance in identifying the product.
Where to find product info
Look for model numbers on the packaging or instruction manual of the AlternatiV+ Screw-In Anchor.
What timeline to expect
Expect refunds or replacements to process within 4-6 weeks after the return is initiated.
If the manufacturer is unresponsive
- Contact Aju Pharm Co. directly for assistance.
- Document all communication attempts and try reaching out via different channels.
How to prevent similar issues
- Always verify product recalls before purchasing medical devices.
- Look for certifications and approvals from relevant health authorities.
Documentation advice
Keep records of your purchase, including receipts and any correspondence regarding the recall.
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Product Details
The recalled product is the AlternatiV+ Screw-In Anchor, with model numbers 20BN4753 and 20BN5503. It was distributed nationwide in California and Puerto Rico. The devices were sold in various healthcare settings.
Key Facts
- Recall Date: December 17, 2025
- Quantity Recalled: 416 units
- Affected States: California, Puerto Rico
- Device Failure Risks: Anchor breakage, bending, pull out
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Safety Guide
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