Smith & Nephew Recalls Ultra-Fast Fix Knot Pusher Suture Cutters
Smith & Nephew is recalling Ultra-Fast Fix Knot Pusher Suture Cutters because the device's sterility may be compromised.
What this means for you
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. The hazard involves a potential compromise in sterility, which poses a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Smith & Nephew, Inc. is recalling the ULTRA-FAST FIX Knot Pusher Suture Cutters (Product Number: 72201537), which are intended for meniscal repair. The recall is being conducted because the sterility of the device may be compromised.
The recall involves 202,279 units. The affected batches were manufactured between April 2010 and April 2014, with corresponding expiration dates ranging from April 2015 to April 2019. The products were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous other countries such as Argentina, Austria, Australia, Belgium, Brazil, Canada, and others.
Healthcare providers and patients should stop using the affected devices and contact Smith & Nephew for further instructions on how to return or dispose of the product.
The recalled product
- Product
- ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 202,279
Distribution
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