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: 00817906020151 T50 SN110 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
Recall
- Recall Number
- Z-2355-2026
- Event Number
- 98978
- Firm
- In2bones USA, LLC
- FEI Number
- 3011580264
- Product Code
- JDR
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- May 11, 2026
- Posted
- June 8, 2026
- Address
- 7750a Trinity Rd, Cordova, TN, 38018-2722
Description
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: 00817906020151 T50 SN110 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
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 criteria. Copies of the Instructions for Use for the NeoSpan SuperElastic Compression Staple with Instruments are available electronically at eifu.conmed.com/eifu. 2. follow the instructions below and respond directly to CONMED with their acknowledgement for the NeoSpan SuperElastic Compression Staple w/Instruments. Step 1: Please review your inventory for any of the devices with the affected lot numbers listed in Table 1. We ask that you contact all departments within your facility and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Step 2a: If you HAVE inventory of any of the affected lot numbers in Table 1. Please do not return any devices as this is a Medical Device Correction; not a removal. Step 2b: If the device has been implanted, update the patient chart using the provided IFU. Complete the medical device recall response form (Attachment I) and acknowledge it via email to [email protected]. The affected products were distributed from August 12, 2025, through January 12, 2026. For questions - contact the Field Action Support Team at 1-800-448-6506 (8:00am to 7:00pm ET, Monday through Friday) or email [email protected].
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,
306 kits