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 is a medical device used in surgical procedures to secure soft tissue to bone. These devices are critical for ensuring proper healing in various orthopedic and surgical applications.
The reported failures of the Genesis Push-In Suture Anchor can lead to complications such as inadequate tissue attachment or additional surgery, posing risks to patient safety.
This recall is not part of a broader industry pattern.
Patients using this device may face serious risks if the device fails. Immediate cessation of use is necessary to prevent potential complications.
The model number is typically printed on the device packaging or the device itself. Check for any UDI codes as well.
Expect the refund or replacement process to take approximately 4-6 weeks.
Keep records of your purchase, any communications regarding the recall, and photos of the product if necessary.
The Genesis Push-In Suture Anchor has model number 10S30002 and is distributed nationwide in California and Puerto Rico. The recall affects 200 units.
Not sure what to do next? Our guide walks you through the process step by step.
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