CLASS II ONGOING Device recall · Reported 4 Feb 2026 · FDA Enforcement Report
Fixone Biocomposite Anchor recalled by Aju Pharm Co
Aju Pharm Co is recalling Fixone Biocomposite 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-1167-2026
- FDA event ID
- 98312
- Recalling firm
- Aju Pharm Co, 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 Biocomposite Anchor
Where it was distributed
US Nationwide distribution in the states of CA & PR.
Questions about this recall
Is Fixone Biocomposite Anchor recalled?
Yes. Aju Pharm Co recalled Fixone Biocomposite Anchor on 17 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1167-2026.
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. BAB-55003ch, BAN-55003b, SAB-30002e; 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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aju Pharm Co
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Genesis Screw-In Anchor recalled by Aju Pharm Co | Aju Pharm Co | Packaging Defects | Nationwide |
| Device | CLASS II | Genesis Dual Thread Screw-In Anchor recalled by Aju Pharm Co | Aju Pharm Co | Packaging Defects | Nationwide |
| Device | CLASS II | AlternatiV+ Max Knotless Anchor recalled by Aju Pharm Co | Aju Pharm Co | Packaging Defects | Nationwide |
| Device | CLASS II | Genesis Knotless Anchor recalled by Aju Pharm Co | Aju Pharm Co | Packaging Defects | Nationwide |
| Device | CLASS II | Fixone Hybrid Anchor recalled by Aju Pharm Co | Aju Pharm Co | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |