FDA Device recall Z-0670-2019
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
- FDA Device
- Class II
- terminated
- Published 2019-01-02
On 2019-01-02 the FDA classified a Class II recall of NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010 by In2bones Usa, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0670-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-14 |
| Published | 2019-01-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | In2bones Usa |
| Distribution | FL, LA, MO, NC, NJ, OH, PA, TN, TX, VA, WI |
Product
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
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.
Identifiers
| code_info | Lot Number: 9G88C0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by In2bones Usa
- REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
FDA Device · Class II · 2026-10-21 · In2bones Usa - NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w…
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FDA Device · Class II · 2018-08-29 · In2bones Usa - CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is ind…
FDA Device · Class II · 2018-08-29 · In2bones Usa
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0670-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.