NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan SuperElastic Com

FDA device recall Z-2355-2026 · posted 2026-06-08 · Open, Classified

Recall details

Recalling firm

In2bones USA, LLC

Reason for recall

Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

JDR

Quantity affected

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,

Date initiated

2026-05-11

Date posted

2026-06-08

Location

Cordova, TN

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