Recall Z-0670-2019 ยท JDR Staple, Fixation, Bone
In2bones USA, LLC
NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
| Date | Nov 14, 2018 |
| 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. |
| Root cause | Employee error |
| Action | The firm initiated the recall by letter on 11/14/2018. The letter requested the return of the product. |
| Quantity | 30 units |
| Distribution | TX, VA, PA, MO, NJ, FL, TN, NC, OH, WI, LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161426 | NeoSpan Compression Staple Impant w/instruments In2bones USA, LLC, Oct 24, 2016 |