Class II — In2bones USA, LLC
| Recalling firm | In2Bones USA, LLC |
|---|---|
| Registered facility | IN2BONES USA, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. |
| Product | REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm |
| Quantity | 29 units |
| Distribution | US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. |
| Initiated | 2026-09-09 |
| Classified | 2026-10-14 |
| Recall number | Z-0157-2027 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-29. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — In2bones USA, LLC (Z-0157-2027).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-29. https://regwarden.com/recall/99846/
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