Recall Z-2355-2026 ยท JDR Staple, Fixation, Bone
In2bones USA, LLC
NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817
| Date | Jun 8, 2026 (initiated May 11, 2026) |
| Status | Open, Classified |
| Reason | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. |
| Root cause | Process control |
| Action | On 05/11/20206, the firm emailed an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customers informing them that In2Bones USA LLC (In2Bones), a CONMED Corporation owned company, is voluntarily recalling NeoSpan SuperElastic Compression Staples with Instruments. In2Bones was notified by it s supplier of an issue affecting certain lots of the NeoSpan SuperElastic Compression Staples with Instruments, in which the Magnetic Resonance (MR) Conditional symbol was missing at the packaging level. Customers are instructed to: 1. Consult the IFU for MR Conditional symbology and MR Conditional use criter |
| Quantity | 306 kits |
| Distribution | U.S.: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MD, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WI O.U.S.: Belgium, Canada, Colombia, France, Ireland, Netherlands, Spain, United Kingdom, |
| 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 |