Aju Pharm Co. recalled 233 Fixone Hybrid Anchors on December 17, 2025, due to multiple reports of device failures. The issues include anchor breakage, bending, and suture breakage. Patients and healthcare providers must 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 Fixone Hybrid Anchor is a surgical device used in various medical procedures to secure tissues. Healthcare providers rely on its reliability during surgeries. Failures can significantly impact patient outcomes.
Device failures like anchor breakage and pull-out can compromise surgical procedures, posing serious risks to patients. Such failures can lead to complications and potential injuries.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers who must stop using the device, leading to potential delays in procedures and impacts on patient care.
Look for model numbers and UDI codes printed on the device packaging or the device itself.
Expect 4-6 weeks for refund or replacement processing after contacting the manufacturer.
Keep all correspondence with the manufacturer, including emails and letters, along with any receipts or records of usage.
The recalled products include Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, and KAPN-55001nc, along with all UDI codes and lots. These devices were distributed nationwide in the United States, specifically in California and Puerto Rico. Each unit was sold in quantities of 233.
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