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Medium risk Medical DevicesClass II

Genesis Push-In Suture Anchor Recall

Genesis Push-In Suture Anchor

Updated December 17, 2025

Genesis Push-In Suture Anchors manufactured by Aju Pharm Co., Ltd. are being recalled due to reports of device failure, including anchor breakage, bending, pull-out, and suture breakage. These failures could compromise surgical repair outcomes.

Is the Aju Pharm Co., Ltd. recalled? Yes. This product was recalled by FDA on December 17, 2025. Details below.

What is recalled

Genesis Push-In Suture Anchor, manufactured by Aju Pharm Co., Ltd.

Am I affected

You're affected if you have had a surgical procedure using a Genesis Push-In Suture Anchor manufactured by Aju Pharm Co., Ltd., or if you work in a medical facility that stocks or uses this device.

What to do right now

If you have received this device or work in a facility that uses it, stop using remaining inventory immediately and contact Aju Pharm Co., Ltd. for further instructions on the recall. If you have had a procedure using this anchor, consult your healthcare provider about potential complications.

The hazard

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Brands affected

Aju Pharm Co., Ltd.
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1171-2026
Classification
Class II
Recalled
December 17, 2025
Read the official notice

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