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 Genesis Screw-In Anchor is a medical device used to secure various medical applications. Users typically include healthcare providers and patients requiring secure anchoring for surgical or medical procedures.
Device failure can result in anchors breaking or pulling out, which poses a risk to patient safety. Suture breakage may also lead to complications in medical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers may face urgent safety concerns and the need for immediate replacement, which could disrupt medical procedures.
Model numbers and UDI codes can typically be found on the product's packaging or user manual.
Expect 4-6 weeks for refund processing after returning the product.
Keep records of your purchase, any communication with the manufacturer, and photos of the product as evidence.
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.
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