Z-2355-2026Class II

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

Name: Z-2355-2026 NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan...
Creator: In2bones USA, LLC
Published: 2026-05-11
License: https://open.fda.gov/license/

In2bones USA, LLC / initiated 2026-05-11 / Open, Classified / root cause: manufacturing process

FDA source

In2bones USA, LLC began a recall of NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan SuperElastic Compression Staple w/Instruments, Size... on 2026-05-11. FDA classified it as Class II and gives the reason as "Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2355-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-11
Posted: 2026-06-08
Recalling firm: In2bones USA, LLC
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.
Product code: JDR Staple, Fixation, Bone
Reason for recall: Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Root cause tag: manufacturing process
FDA 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 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].
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,
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2355-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2355-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-08

Product code JDR

K161426Class IINeoSpan Compression Staple Impant w/instrumentsIn2bones USA, LLC / cleared 2016-10-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)