In2Bones NeoSpan SuperElastic Compression Staple Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
In2Bones USA, LLC is recalling 306 kits of NeoSpan SuperElastic Compression Staple w/Instruments due to a missing Magnetic Resonance Conditional Symbol on packaging and labels.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 27, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
In2Bones USA, LLC initiated a voluntary recall of certain NeoSpan SuperElastic Compression Staple w/Instruments kits because the Magnetic Resonance Conditional Symbol is missing from the carton, inner tray, and patient label.
Which Products Are Affected
The recall covers 306 kits distributed in AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MD, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WI and internationally in Belgium, Canada, Colombia, France, Ireland, Netherlands, Spain, and the United Kingdom. Affected catalog numbers and lot codes include:
- T50 SN010 (lots 1962242, 1964665, 2054541, 2039361)
- T50 SN012 (lot 1963511)
- T50 SN020 (lots 1971252, 1990642, 2027441)
- T50 SN110 (lot 1971241)
- T50 SN115 (lot 19647210)
- T50 SN118 (lot 1990631)
Recall number Z-2355-2026. The product is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
What You Should Do
Consumers and healthcare providers should check inventory for the affected lots and contact In2Bones USA, LLC for return or replacement instructions.
Why This Matters
The missing symbol may result in improper use during MRI procedures, posing a remote risk of adverse events.
Source
FDA recall Z-2355-2026, report date 20260617.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,267 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 27, 2026.
Frequently Asked Questions
Common questions about this FDA recall.