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 Anchors
- Model numbers
- Model No. 20KPN4751, 20KPN5501, 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+ Max Knotless Anchor is a medical device used in surgical procedures to securely anchor sutures. Surgeons use this device to ensure stability during various surgical applications, making it essential for patient safety.
Why This Is Dangerous
Failures such as anchor breakage or suture breakage can lead to compromised surgical outcomes, potentially causing harm to patients. These failures present a serious risk during procedures that require reliable anchoring.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a high urgency for consumers, particularly healthcare providers and patients relying on these anchors for surgical procedures. The device's failure could lead to significant complications and necessitate immediate attention for safety.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device packaging or label.
- Verify if your device falls under the recalled models: 20KPN4751, 20KPN5501, or any UDI codes.
- Review any correspondence from Aju Pharm Co. regarding the recall.
Where to find product info
Serial numbers and model numbers can typically be found on the device packaging and accompanying documentation.
What timeline to expect
Expect a timeline of 4-6 weeks for any processing related to refunds or replacements.
If the manufacturer is unresponsive
- Contact Aju Pharm Co. directly for follow-up.
- File a complaint with the FDA if unresponsive.
How to prevent similar issues
- Research alternative medical devices with a proven safety record.
- Consult healthcare professionals about device options before purchasing.
- Look for devices certified by relevant safety standards.
Documentation advice
Keep records of all communications with the manufacturer, including emails or letters, as well as any receipts related to the device.
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Product Details
The recall affects 2,569 units of the AlternatiV+ Max Knotless Anchor. The recalled models include Model No. 20KPN4751 and 20KPN5501, among others. The products were distributed nationwide in California and Puerto Rico.
Key Facts
- Recalled on December 17, 2025
- High hazard level
- Stop using the device immediately
- Contact healthcare provider for instructions
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Safety Guide
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