- Recalling firm
- In2bones USA, LLC
- Reason for recall
- Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
- Affected products (lot / model / serial)
- UDI: 00817906023992/Lot: GM008380; GM007868
- Units affected
- 29 units
- Distribution pattern
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Firm location
- Cordova, TN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0157-2027
- Recall initiated
- September 9, 2026
- FDA classification date
- October 14, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99846
- Last updated on HTM Vibe
- October 27, 2026
