Device recall
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
- Recall number
- Z-0157-2027
- Event id
- 99846
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- In2bones USA, LLC
- Report date
- Oct 21, 2026
- Posted
- Oct 14, 2026
- Initiated
- Sep 9, 2026
- Center classification date
- Oct 14, 2026
- Product code
- HWC
- Device type
- Screw, Fixation, Bone
- Reason
- Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
- Root cause
- Error in labeling
- Quantity
- 29 units
- Code info
- UDI: 00817906023992/Lot: GM008380; GM007868
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K170518
- Location
- Cordova, TN, United States