- Recalling firm
- restor3d Inc.
- Reason for recall
- Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.
- Affected products (lot / model / serial)
- System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
- Units affected
- 2
- Distribution pattern
- US Nationwide distribution in the states of FL, CO.
- Firm location
- Durham, NC, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3178-2026
- Recall initiated
- July 27, 2026
- FDA classification date
- September 16, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99512
- Last updated on HTM Vibe
- September 29, 2026