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 Genesis Dual Thread Screw-In Anchor is a medical device used in various surgical procedures to secure sutures and other materials. Consumers typically purchase these anchors for their reliability in medical settings.
The reported failures include breakage and pull-out of the anchors, which can lead to serious complications during surgical procedures. This jeopardizes patient safety and can result in additional medical interventions.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face potential safety risks due to the device failures. Immediate action is required to prevent complications associated with using the recalled anchors.
Model numbers and UDI codes are typically found on the product packaging or the device itself.
Expect processing for refunds or replacements to take 4-6 weeks after the return of the product.
Keep a record of all communications regarding the recall, including emails, letters, and phone call notes.
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.
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