FDA Recalls Signia Tri-Staple 2.0 Devices Due to Missing Pin Components
The FDA is recalling Signia Tri-Staple 2.0 devices because missing pin components may cause incomplete staple formation, leading to serious surgical complications.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a defect that can lead to serious injuries such as sepsis, peritonitis, and pneumothorax, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Signia Tri-Staple 2.0 Black 60mm Extra Thick Reloads (SIG60AXT) manufactured by Covidien LLC. The recall involves 3,113,280 units that were distributed domestically and internationally.
The recall is being issued because the devices may be missing one of two pin components that maintain the alignment of the device jaws. This defect can result in incomplete staple formation during use. Incomplete staple formation may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax, which can result in the potential for infection and/or sepsis.
The FDA classifies this as a Class II recall. Healthcare providers and facilities should identify and stop using the affected lots listed in the recall notice. Patients who have had these devices used in their surgery should contact their healthcare provider if they experience symptoms such as bleeding, infection, or other complications.
The recalled product
- Product
- SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
- Manufacturer
- Covidien LLC
- Affected units
- 3,113,280
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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