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 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.
The recall stems from reports of device failures, including anchor breakage and suture breakage. These failures could pose significant risks in medical settings, potentially leading to complications during procedures.
There have been multiple reports of device failure, but specific incident counts have not been disclosed. The nature of the failures raises concerns about patient safety in surgical applications.
Patients and healthcare providers should stop using the Fixone Hybrid Anchor immediately. To follow the recall instructions, contact Aju Pharm Co., Ltd. or consult your healthcare provider.
For further details, contact Aju Pharm Co., Ltd. directly. Visit the FDA's recall report at the provided link for additional guidance.
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