STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device recalled
Ethicon LLC is recalling STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device (Product Code SXPP2B400-11, Lot 104DBB) due to potential barb non-engagement that could affect surgical outcomes.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a potential device malfunction (barb non-engagement) that could affect surgical outcomes but presents a theoretical rather than confirmed risk of harm.
Plain-English summary
Ethicon LLC is recalling the STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, Product Code SXPP2B400-11, Lot Number 104DBB. The device is used for tissue control during surgical procedures.
The recall is due to potential for barb non-engagement, which could impact the device's intended function. A total of 516 units have been identified.
The affected device was distributed worldwide and within the United States in Arkansas, Arizona, California, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Minnesota, North Carolina, New Hampshire, New Mexico, Texas, Virginia, Washington, and Wisconsin. International distribution includes Singapore and Malaysia. The device is identified by GTIN 10705031464568 (each) or 30705031464562 (box of 12).
Customers who have received this product should contact Ethicon LLC to determine if they have affected units and receive guidance on appropriate actions.
The recalled product
- Product
- STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
- Manufacturer
- ETHICON, LLC
- Affected units
- 516
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 (2)
- Product Code: SXPP2B400-11. GTIN: 10705031464568 (each)
- 30705031464562 (box of 12). Lot Number: 104DBB.
Distribution
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