Aju Pharm Co. recalled 416 units of its AlternatiV+ Screw-In Anchor on December 17, 2025, after reports of significant device failures. The defects include anchor breakage, bending, and suture breakage. Patients and healthcare providers should 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 AlternatiV+ Screw-In Anchor is a medical device used for various surgical applications. It allows for secure attachment during medical procedures, making it crucial for patient safety.
The reported failures of the anchor can lead to inadequate securement during surgical procedures, posing significant health risks. Such failures can compromise the effectiveness of the surgery and result in additional medical complications.
This recall is not part of a broader industry pattern.
Patients relying on this device may face serious health risks, necessitating immediate action to cease use and consult healthcare providers.
Look for model numbers on the packaging or instruction manual of the AlternatiV+ Screw-In Anchor.
Expect refunds or replacements to process within 4-6 weeks after the return is initiated.
Keep records of your purchase, including receipts and any correspondence regarding the recall.
The recalled product is the AlternatiV+ Screw-In Anchor, with model numbers 20BN4753 and 20BN5503. It was distributed nationwide in California and Puerto Rico. The devices were sold in various healthcare settings.
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