In2bones USA, LLC recalls NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Nam…

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 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.

• FDA enforcement recordOfficial FDA database entry for Z-2355-2026
• FDA 510(k) clearance · K161426The device's official FDA premarket clearance record
• FDA device classification · JDROfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3030The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find In2bones USA, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.