Aju Pharm Co. recalled 200 units of the Genesis Push-In Suture Anchor on December 17, 2025. Users reported serious device failures including anchor breakage and suture breakage. Consumers 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 Push-In Suture Anchor has model number 10S30002 and is distributed nationwide in California and Puerto Rico. The recall affects 200 units.
Reports indicate severe failures, including anchor breakage, anchor bending, and suture breakage. These failures pose a high risk to patients undergoing procedures requiring this device.
There are multiple reports of incidents involving device failures. Specific injury counts or detailed descriptions of injuries have not been disclosed.
Stop using the Genesis Push-In Suture Anchor immediately. Follow the recall instructions provided by the manufacturer and contact Aju Pharm Co., Ltd. or your healthcare provider for further guidance.
For further assistance, contact Aju Pharm Co., Ltd. through the details provided in the notification letter. More information is available at the FDA recall page.
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