REF: P65 ST862 CoLag SCREW recall (In2bones USA, LLC)
Medical deviceClass IIOngoing
Summary: In2bones USA, LLC is recalling REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm. Reason: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
What is being recalled
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Why
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. (states named: Florida, Georgia, Hawaii, North Carolina, Ohio, Pennsylvania, South Dakota, Texas, Virginia)
How to tell if yours is affected
UDI: 00817906023992/Lot: GM008380; GM007868
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0157-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | September 9, 2026 |
| Reported | October 21, 2026 |
| Company | In2bones USA, LLC |
| Company location | Cordova, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 29 units |
More recalls from In2bones USA, LLC · all medical device recalls · recalls from September 2026