Aju Pharm Co. recalled 600 units of Genesis Screw-In Anchors on December 17, 2025. Reports indicate serious device failures, including anchor breakage and suture breakage. Healthcare providers and patients should stop using these anchors 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 Screw-In Anchors, Model No. 10B45003, 10B55003, and 10B65003. These anchors were distributed nationwide in the United States, specifically in California and Puerto Rico.
The recall stems from reports of significant failures with the devices. Issues include anchor breakage, bending, pull out, and suture breakage.
There are no specific numbers of injuries or incidents reported in association with the recall. The nature of device failure can pose serious risks to patients.
Patients and healthcare providers should stop using the recalled anchors immediately. Follow the recall instructions provided by the manufacturer and contact Aju Pharm Co., Ltd. for further guidance.
For more information, contact Aju Pharm Co., Ltd. or visit the FDA’s recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1168-2026.
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