FDA recall, , Moderate risk
In2bones CoLag Screw FT
Bone screws labeled as fully threaded are actually partially threaded.
Summary by Recall Canary from the FDA notice
What happened
In2bones USA, LLC is recalling its REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm bone screws because of a labeling error: screws specified as fully threaded are actually partially threaded. The recall involves 29 units and began on September 9, 2026, with the FDA's Enforcement Report adding it on October 14, 2026.
The product was distributed nationwide in the states of Florida, Georgia, Hawaii, North Carolina, Ohio, Pennsylvania, South Dakota, Texas and Virginia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
REF: P65 ST862 CoLag Screw, FT, 6.7X62.5 mm
- UDI-DI
- 00817906023992
- Lot code
- GM008380
- GM007868
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Florida, Georgia, Hawaii, North Carolina, Ohio, Pennsylvania, South Dakota, Texas, Virginia.
- Company
- In2bones USA, LLC
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99846
- Recall number
- Z-0157-2027
- Quantity recalled
- 29 units
All recalls from In2bones USA, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
