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 | Terminated |
| Reason | The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit. |
| Product | NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010 |
| Quantity | 30 units |
| Distribution | TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA |
| Initiated | 2018-11-14 |
| Classified | 2018-12-22 |
| Terminated | 2019-05-08 |
| Recall number | Z-0670-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — In2bones USA, LLC (Z-0670-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81655/
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