FDAFDA recall Z-0157-2027 · Oct 21, 2026
In2bones USA, LLC: REF: P65 ST862 CoLag SCREW recall
Recall found
Product
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Reason for recall
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI: 00817906023992/Lot: GM008380; GM007868
- Quantity
- 29 units
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
- Recalling firm
- In2bones USA, LLC, Cordova, TN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-09-09
Source: openFDA enforcement record Z-0157-2027 · search recall number Z-0157-2027 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 26, 2026, 8:14 PM EDT. The agency notice is the final word.