- Recalling firm
- United Orthopedic Corp.
- Reason for recall
- Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
- Affected products (lot / model / serial)
- Lot Code: Product Number 9323-5310; UDI-DI 04719886908060; Lot number 25FC58
- Units affected
- 3
- Distribution pattern
- US Nationwide distribution in the states of Texas and Michigan.
- Firm location
- Kaohsiung, Taiwan
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2897-2026
- Recall initiated
- March 19, 2026
- FDA classification date
- August 6, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99025
- Last updated on HTM Vibe
- August 18, 2026