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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0670-2019%22
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