FDAFDA · Food and drugs·Recall number Z-1171-2026
Genesis Push-In Suture Anchor
Published February 4, 2026 · Recall initiated: December 17, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aju Pharm Co., Ltd.
- Distributor
- US Nationwide distribution in the states of CA & PR.
- Lot
- Model No. 10S30002; All UDI Codes; All Lots.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Korea (the Republic of)
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.