CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report
Fixone Hybrid Anchor recalled by Aju Pharm Co
Aju Pharm is recalling Fixone Hybrid Anchor, distributed nationwide in the US. The recall was initiated on 17 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1166-2026
- FDA event ID
- 98312
- Recalling firm
- Aju Pharm, Seongnam, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Dec 2025
- FDA classified
- 26 Jan 2026
- Reported
- 4 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 17 Dec 2025 | Recall initiated by company | |
| 26 Jan 2026 | Classified by FDA | +40 days |
| 4 Feb 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Fixone Hybrid Anchor
Where it was distributed
US Nationwide distribution in the states of CA & PR.
Questions about this recall
Why was it recalled?
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Which lots are affected?
Model No. KAPN-47501nc, KAPN-55001c, KAPN-55001na, KAPN-55001nc; All UDI Codes; All Lots.
Where was it sold?
US Nationwide distribution in the states of CA & PR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 98312This product is part of a recall event; the main page for the event is AlternatiV+ Screw-In Anchor recalled by Aju Pharm Co.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | AlternatiV+ Screw-In Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide | |
| CLASS II | Genesis Push-In Suture Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide | |
| CLASS II | Fixone Biocomposite Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide | |
| CLASS II | Genesis Knotless Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide | |
| CLASS II | AlternatiV+ Max Knotless Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide | |
| CLASS II | Genesis Dual Thread Screw-In Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide | |
| CLASS II | Genesis Screw-In Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide |
More recalls from Aju Pharm
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Genesis Screw-In Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide |
| Device | CLASS II | Genesis Dual Thread Screw-In Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide |
| Device | CLASS II | AlternatiV+ Max Knotless Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide |
| Device | CLASS II | Genesis Knotless Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide |
| Device | CLASS II | Fixone Biocomposite Anchor recalled by Aju Pharm Co | Aju Pharm | Packaging Defects | Nationwide |
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| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |