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 AlternatiV+ Max Knotless Anchor is a medical device used in surgical procedures to securely anchor sutures. Surgeons use this device to ensure stability during various surgical applications, making it essential for patient safety.
Failures such as anchor breakage or suture breakage can lead to compromised surgical outcomes, potentially causing harm to patients. These failures present a serious risk during procedures that require reliable anchoring.
This recall is not part of a broader industry pattern.
The recall poses a high urgency for consumers, particularly healthcare providers and patients relying on these anchors for surgical procedures. The device's failure could lead to significant complications and necessitate immediate attention for safety.
Serial numbers and model numbers can typically be found on the device packaging and accompanying documentation.
Expect a timeline of 4-6 weeks for any processing related to refunds or replacements.
Keep records of all communications with the manufacturer, including emails or letters, as well as any receipts related to the device.
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.
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