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FDA-Device2026-02-04Class IIPROCESSING DEFECT

Aju Pharm AlternatiV+ Max Knotless Anchor recalled for device failure risk

Aju Pharm
OTHERNationwide distribution

Stop using Aju Pharm AlternatiV+ Max anchors

Aju Pharm's AlternatiV+ Max Knotless Anchor surgical device has been recalled due to reports of failure, including anchor breakage, bending, and pulling out during use. The issue affects all lots of models 20KPN4751 and 20KPN5501 distributed in California and Puerto Rico.

  • Stop using affected AlternatiV+ Max Knotless Anchor devices immediately
  • Contact your healthcare provider or hospital if you have questions about your procedure
  • Report any device failures or complications to the FDA MedWatch program
Hazard

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

Sold states
US Nationwide distribution in the states of CA & PR.
Affected count
2,569 units
Manufactured in
Room 201, Room 207, Bl A, Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang, Seongnam, N/A, Korea (the Republic of)
Products
AlternatiV+ Max Knotless Anchor

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1172-2026

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