Aju Pharm Co. recalled 2,569 units of the AlternatiV+ Max Knotless Anchor on December 17, 2025, following reports of device failures. Issues include anchor breakage and suture breakage, posing significant risks to patients. Consumers should stop using the device immediately and follow recall instructions.
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 recall affects 2,569 units of the AlternatiV+ Max Knotless Anchor. The recalled models include Model No. 20KPN4751 and 20KPN5501, among others. The products were distributed nationwide in California and Puerto Rico.
Reports indicate multiple failure modes involving the AlternatiV+ Max Knotless Anchor. Risks include anchor breakage, bending, pull-out, and suture breakage, which can compromise surgical procedures.
There are no reported injuries or deaths associated with this recall. However, the high hazard level indicates a significant risk of failure during use.
Patients and healthcare providers must stop using the device immediately. Contact Aju Pharm Co., Ltd. or your healthcare provider for further instructions and follow the recall protocols provided.
For more information, contact Aju Pharm Co., Ltd. directly or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1172-2026.
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