Class 2 Device Recall NeoSpan SuperElastic Compression Staple w/Instruments

• Date Initiated by Firm: May 11, 2026
• Date Posted: June 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2355-2026
• Recall Event ID: 98978
• 510(K)Number: K161426
• Product Classification: Staple, fixation, bone - Product Code JDR
• Product: 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.
• Code Information: Catalog No. Lot Code T50 SN010 1962242 1964665 2054541 2039361 T50 SN012 1963511 T50 SN020 1971252 1990642 2027441 T50 SN110 1971241 T50 SN115 19647210 T50 SN118 1990631
• FEI Number: 3011580264
• Recalling Firm/ Manufacturer: In2bones USA, LLC; 7750a Trinity Rd; Cordova TN 38018-2722
• Manufacturer Reason for Recall: Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
• FDA Determined 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 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 neospan2026@conmed.com. 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 neospan2026@conmed.com.
• Quantity in Commerce: 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,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JDR