Aju Pharm Co. recalled 1,163 units of Genesis Knotless Anchor on December 17, 2025, after reports of device failures. Issues include anchor breakage and suture breakage. Patients and healthcare providers must stop using the device immediately.
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
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
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The Genesis Knotless Anchor is a medical device used for anchoring sutures in surgical procedures. Surgeons prefer it for its ease of use and effectiveness in securing tissues during operations.
Device failures lead to potential surgical complications, including insufficient tissue anchoring and increased risk during procedures. These issues can cause significant consequences for patient safety.
This recall is not part of a broader industry pattern.
Consumers must stop using the device immediately, leading to potential delays in surgical procedures. The urgency of addressing the recall is high due to the risk of device failure.
Model numbers and UDI codes can typically be found on the product packaging or accompanying documentation.
Expect a refund or replacement process to take approximately 4 to 6 weeks after submission of your request.
Document all communications regarding the recall, including emails, letters, and any calls made. Keep receipts and product packaging as evidence.
The Genesis Knotless Anchor is a medical device used in surgical procedures. The recalled models include Model No. 10KPN4751 and 10KPN5501, along with all UDI Codes and Lots. The product was distributed nationwide in the U.S., specifically in California and Puerto Rico.
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