NeoSpan compression staple kits missing Magnetic Resonance Conditional labeling symbol
NeoSpan SuperElastic Compression Staple kits are being recalled because the Magnetic Resonance Conditional symbol is missing from the carton, inner tray and patient label. 306 kits affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall arising from a missing labeling symbol with no product defect or consequence described in the source, which fits the Moderate labeling band.
Plain-English summary
NeoSpan SuperElastic Compression Staple with Instruments kits from In2bones USA, LLC are being recalled, spanning catalog numbers including T50 SN010, T50 SN012, T50 SN020, T50 SN110, T50 SN115 and T50 SN118. The action covers 306 kits.
The stated reason is that the Magnetic Resonance Conditional symbol is missing from the carton, the inner tray and the patient label. The FDA classified the action as Class II. The source does not describe any defect in the implants themselves.
Distribution was across 25 US states and internationally to Belgium, Canada, Colombia, France, Ireland, the Netherlands, Spain and the United Kingdom. The kits are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog numbers, UDI-DI codes and lot codes in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- 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…
- Manufacturer
- In2bones USA, LLC
- Affected units
- 306
Distribution
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