Aju Pharm Co. recalled 400 Dual Thread Screw-In Anchors on December 17, 2025. The recall follows reports of device failures including breakage and pull-out incidents. Healthcare providers and patients should stop using these devices 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 recalled products include Genesis Dual Thread Screw-In Anchors, Model No. 10N47502 and 10N55002. The devices were distributed nationwide in the United States, particularly in California and Puerto Rico. The quantity recalled is 400 units.
Reports indicate multiple device failures, including anchor breakage, bending, pull-out incidents, and suture breakage. These failures pose a high risk to patient safety, potentially leading to serious complications.
The recall is classified as Class II, indicating a high potential for serious injury. No specific incident or injury counts have been reported, but the nature of the failures suggests a significant risk.
Patients and healthcare providers should immediately stop using the recalled anchors. Follow the manufacturer's instructions for returning the product and seek guidance from Aju Pharm Co. or your healthcare provider.
For further information, contact Aju Pharm Co., Ltd. via the link provided in the recall notice or consult your healthcare provider for additional instructions.
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