Smith & Nephew Whipknot Soft Tissue Cinch Suture Recalled for Sterility Breach
Smith & Nephew is recalling Whipknot Soft Tissue Cinch sutures because sterile packaging was breached, compromising sterility. The recall covers 34,065 units distributed worldwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a compromised sterile barrier for a surgical implant, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
Smith & Nephew, Inc. is recalling 34,065 units of Whipknot Soft Tissue Cinch (USP#5) suture, Product Number 7211015. The recall is due to a breach in the sterile packaging, which compromises the sterility of the medical device. This suture is used during ligament reconstruction procedures.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international markets such as Australia, Canada, Germany, France, and the United Kingdom. The recall encompasses a specific list of lot codes, ranging from 50387867 to 50605882.
Healthcare providers and facilities should stop using the affected lots of the Whipknot Soft Tissue Cinch suture and contact Smith & Nephew for instructions on how to return the product. Patients who have had this specific suture used in their surgery should consult their healthcare provider if they have concerns regarding the sterility of the device.
The recalled product
- Product
- Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.
- Manufacturer
- Smith & Nephew, Inc.
- Category
- Medical Device — Surgical Suture
- Affected units
- 34,065
Distribution
Distributed nationwide across the United States.
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