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Class IIOngoing

In2bones USA, LLC recalls REF: P65 ST862 CoLag SCREW

Recall date · record updated Oct 21, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
In2bones USA, LLC
Reason
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99846…

Products

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

    Codes/lots: UDI: 00817906023992/Lot: GM008380; GM007868Quantity: 29 unitsRecall no. Z-0157-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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