Smith & Nephew Whipknot Sutures Recalled for Sterile Barrier Defect
Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because packaging design flaws may allow sterile barrier breaches.
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: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential sterile barrier breach, which fits the criteria for a moderate severity recall involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Smith & Nephew, Inc. is recalling 22 units of Whipknot Soft Tissue Cinch #5 Sutures (PN: 7211015) due to a packaging design issue. The Tyvek film on the pouches has a design that is insufficient to prevent potential sterile barrier breaches, specifically pin holes.
The affected products were distributed to accounts in Arizona, Maine, New York, Ohio, Pennsylvania, Tennessee, Vermont, and Puerto Rico. The recall involves specific batch numbers, including 50498479, 50526605, 50527117, 50553176, 50579348, 50581344, 50588245, 50590542, 50591919, 50592295, and 50603355. The source notes that a limited number of previously recalled devices were inadvertently redistributed.
Healthcare providers and facilities should check their inventory for these specific batch numbers and stop using the affected sutures. Users should contact Smith & Nephew for instructions on returning or replacing the products.
The recalled product
- Product
- Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Batch No. 50498479
- 50526605
- 50527117
- 50553176
- 50579348
- 50581344
- 50588245
- 50590542
- 50591919
- 50592295 & 50603355
Distribution
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