FDA Medical devices recall ·
Fixone Biocomposite Anchor recall
- Recall number
- Z-1167-2026
- Date
- (initiated December 17, 2025)
- Company / brand
- Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A, Seongnam, N/A, Korea (the Republic of) - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1,088 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Fixone Biocomposite Anchor
Why was it recalled?
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. BAB-55003ch, BAN-55003b, SAB-30002e; All UDI Codes; All Lots.
Distribution
US Nationwide distribution in the states of CA & PR.
States: California Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1167-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.