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.
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. 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
Related recalls
Same manufacturer · Smith & Nephew, Inc.
See all →- HighTRIGEN proximal humeral nails are missing their distal holes
FDA (Devices) · 2026-06-24
- ModerateBone fixation screws recalled over a labeling error on one lot
FDA (Devices) · 2025-12-24
- ModerateSmith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
FDA (Devices) · 2025-05-28
- HighBIORAPTOR Suture Anchors Recalled for Sterile Barrier Packaging Breach
FDA (Devices) · 2024-12-11
- HighSmith & Nephew Bipolar Hip Implant Component Recalled for Oversized Retainer Ring
FDA (Devices) · 2024-11-13
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighSmith and Nephew TWINFIX QUICK-T Knot Pusher Suture Cutter Recalled for Sterility Breach
FDA (Devices) · 2016-07-27
- HighSmith & Nephew Recalls Ultra Fast-Fix Absorbable Suture Anchors
FDA (Devices) · 2020-10-28
- HighSmith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach
FDA (Devices) · 2014-07-23
- HighSmith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach
FDA (Devices) · 2014-07-23
- HighSmith & Nephew Recalls SUTUREFIX Ultra S Devices Due to Sterility Breach
FDA (Devices) · 2014-07-23
- SevereSmith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach
FDA (Devices) · 2014-07-23