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 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.
The recall stems from multiple reports of device failure. Problems include anchor breakage, anchor bending, anchor pull out, and suture breakage.
The recall does not specify the exact number of incidents but classifies the hazard level as high. There are concerns about the safety of patients using the affected devices.
Patients and healthcare providers should stop using the Fixone Biocomposite Anchor immediately. Contact Aju Pharm Co., Ltd. or your healthcare provider for instructions on returning the device.
For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1167-2026.
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