Aju Pharm Co. recalled 1,088 units of its Fixone Biocomposite Anchor on December 17, 2025, due to serious device failures. Reports include anchor breakage, bending, and suture breakage. Healthcare providers and patients 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 Biocomposite Anchor is used in surgical procedures to anchor sutures securely. It is typically used in orthopedic surgeries and other medical applications requiring tissue fixation.
The device failure can lead to serious complications during surgical procedures. Breakage or bending of the anchor compromises its effectiveness and can pose risks to patient safety.
This recall is not part of a broader industry pattern.
The recall may cause significant delays in surgical procedures for patients relying on the affected device. It emphasizes the importance of using safe and reliable medical devices.
Serial numbers and UDI codes can typically be found on the product packaging or the device itself.
4-6 weeks for refund processing once the product is returned.
Keep records of your purchase, including receipts and correspondence with the manufacturer.
The recalled Fixone Biocomposite Anchors include Model No. BAB-55003ch, BAN-55003b, and SAB-30002e. The devices were distributed nationwide in California and Puerto Rico. Affected products include all UDI codes and lots.
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