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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Fixone, Genesis, and AlternatiV+ Surgical Anchors Recalled for Device Failure

Agency Publication Date: January 26, 2026
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Summary

Aju Pharm Co., Ltd. is recalling 6,669 units of various surgical anchors sold under the Fixone, Genesis, and AlternatiV+ brands. The recall was initiated following reports of device failures, including anchors breaking, bending, or pulling out of position, as well as suture breakage and damaged secondary packaging. These products were distributed in California and Puerto Rico.

Risk

If these anchors fail, they may break or pull out during or after surgery, potentially leading to improper healing, patient injury, or the need for additional surgical procedures to replace the failed device.

What You Should Do

  1. This recall affects Fixone Hybrid and Biocomposite Anchors, Genesis Screw-In, Dual Thread, Knotless, and Push-In Suture Anchors, and AlternatiV+ Max Knotless and Screw-In Anchors.
  2. Check your medical inventory or surgical records for affected model numbers such as KAPN-47501nc, 10B45003, or 20KPN4751. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact Aju Pharm Co., Ltd. or your surgical supply distributor to arrange for the return, replacement, or correction of any remaining affected stock.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Fixone Hybrid Anchor
Model / REF:
KAPN-47501nc
KAPN-55001c
KAPN-55001na
KAPN-55001nc
Lot Numbers:
All Lots
UDI:
All UDI Codes

Recall Number: Z-1166-2026. Quantity: 233 units.

Product: Fixone Biocomposite Anchor
Model / REF:
BAB-55003ch
BAN-55003b
SAB-30002e
Lot Numbers:
All Lots
UDI:
All UDI Codes

Recall Number: Z-1167-2026. Quantity: 1,088 units.

Product: Genesis Screw-In Anchor
Model / REF:
10B45003
10B55003
10B65003
Lot Numbers:
All Lots
UDI:
All UDI Codes

Recall Number: Z-1168-2026. Quantity: 600 units.

Product: Genesis Dual Thread Screw-In Anchor
Model / REF:
10N47502
10N55002
Lot Numbers:
All Lots
UDI:
All UDI Codes

Recall Number: Z-1169-2026. Quantity: 400 units.

Product: Genesis Knotless Anchor
Model / REF:
10KPN4751
10KPN5501
Lot Numbers:
All Lots
UDI:
All UDI Codes

Recall Number: Z-1170-2026. Quantity: 1,163 units.

Product: Genesis Push-In Suture Anchor
Model / REF:
10S30002
Lot Numbers:
All Lots
UDI:
All UDI Codes

Recall Number: Z-1171-2026. Quantity: 200 units.

Product: AlternatiV+ Max Knotless Anchor
Model / REF:
20KPN4751
20KPN5501
Lot Numbers:
All Lots
UDI:
All UDI Codes

Recall Number: Z-1172-2026. Quantity: 2,569 units.

Product: AlternatiV+ Screw-In Anchor
Model / REF:
20BN4753
20BN5503
Lot Numbers:
All Lots
UDI:
All UDI Codes

Recall Number: Z-1173-2026. Quantity: 416 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98312
Status: Active
Manufacturer: Aju Pharm Co., Ltd.
Sold By: Hospitals; Surgical centers; Medical device distributors
Manufactured In: Korea (the Republic of)
Units Affected: 8 products (233 units; 1,088 units; 600 units; 400 units; 1,163 units; 200 units; 2,569 units; 416 units)
Distributed To: California, Puerto Rico

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.