FDA recall, , Moderate risk
Aju Pharm Fixone, Genesis and AlternatiV+ Anchors
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Summary by Recall Canary from the FDA notice
What happened
Aju Pharm Co., Ltd., of Seongnam, Korea (the Republic of), recalled Genesis Screw-In Anchor, Fixone Hybrid Anchor, Fixone Biocomposite Anchor, Genesis Knotless Anchor, Genesis Push-In Suture Anchor, AlternatiV+ Screw-In Anchor, Genesis Dual Thread Screw-In Anchor, and AlternatiV+ Max Knotless Anchor due to reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
The recall began December 17, 2025, and was added to FDA's Enforcement Report on January 26, 2026. Distribution was US Nationwide in the states of CA and PR.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
8 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Genesis Screw-In Anchor
- Lot code
- Model No. 10B45003, 10B55003, 10B65003; All UDI Codes; All Lots.
Fixone Hybrid Anchor
- Lot code
- Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc; All UDI Codes; All Lots.
Fixone Biocomposite Anchor
- Lot code
- Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.
Genesis Knotless Anchor
- Lot code
- Model No. 10KPN4751, 10KPN5501; All UDI Codes; All Lots.
Genesis Push-In Suture Anchor
- Lot code
- Model No. 10S30002; All UDI Codes; All Lots.
AlternatiV+ Screw-In Anchor
- Lot code
- Model No. 20BN4753, 20BN5503; All UDI Codes; All Lots.
Genesis Dual Thread Screw-In Anchor
- Lot code
- Model No. 10N47502, 10N55002; All UDI Codes; All Lots.
AlternatiV+ Max Knotless Anchor
- Lot code
- Model No. 20KPN4751, 20KPN5501; All UDI Codes; All Lots.
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California & PR.
- Company
- Aju Pharm Co., Ltd.Seongnam, Korea (the Republic of)
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98312
- Recall numbers
- Z-1166-2026 to Z-1173-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
