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 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.
Reports indicate multiple failures of the device, including anchor breakage, bending, and suture breakage. These failures pose a high risk of complications during surgical procedures.
The recall follows reports of device failures, but no specific injuries or complications have been reported at this time. The number of reported incidents includes failures but does not specify injuries.
Patients and healthcare providers should immediately stop using the Genesis Knotless Anchor. Contact Aju Pharm Co., Ltd. or your healthcare provider for further instructions regarding the recall.
For more information, contact Aju Pharm Co., Ltd. directly. Visit the official recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1170-2026.
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