← FDA ENFORCEMENT
Z-0157-2027Class II

In2bones USA, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
In2bones USA, LLC
Product type
Device
Status
Ongoing
Report date
2026-10-21
Distribution
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Firm state
TN
Product quantity
29 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

Product description

REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm

Code / lot info

UDI: 00817906023992/Lot: GM008380; GM007868

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →