Aju Pharm Co. recalled 416 units of its AlternatiV+ Screw-In Anchor on December 17, 2025, after reports of significant device failures. The defects include anchor breakage, bending, and suture breakage. Patients and healthcare providers should 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 recalled product is the AlternatiV+ Screw-In Anchor, with model numbers 20BN4753 and 20BN5503. It was distributed nationwide in California and Puerto Rico. The devices were sold in various healthcare settings.
The recall involves risks of device failure, including anchor breakage and pull-out. These failures could lead to serious complications for patients depending on the device for medical procedures.
Reports indicate multiple instances of device failure, including breakage and suture issues. No specific injury or death counts have been disclosed.
Stop using the AlternatiV+ Screw-In Anchor immediately. Follow instructions from Aju Pharm Co. or contact your healthcare provider for guidance on next steps.
For further assistance, contact Aju Pharm Co., Ltd. at their official website or through the FDA recall notice.
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