Sinu-Knit RR 600Recalls & reported problems
Smith & Nephew, Inc. · RAPID RHINO SINU-KNIT DISSOLVABLE DRESSING · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470005394), received between Dec 13, 2021 and Dec 13, 2021 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cellulitis1
- Granuloma1
- Hematoma1
- Prolapse1
- Scar Tissue1
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON LITERATURE REVIEW "MYOSPHERULOSIS AS A COMPLICATION OF FUNCTIONAL ENDOSCOPIC SINUS SURGERY: A DOUBLE CASE REPORT", AFTER A SINUS SURGERY OF THE MAXILLARY AND ETHMOIDAL SINUSES BILATERALLY, IN COMBINATION WITH A SEPTOPLASTY AND A CONCHOTOMY OF THE LOWER TURBINATES BECAUSE OF CHRONICAL NASAL OBSTRUCTION AND NASAL DECONGESTANT ABUSE, A SINU-KNIT WITH A COMBINED CORTICOSTEROID AND ANTIBIOTIC OINTMENT(TERRA-CORTRIL®: HYDROCORTISONE + OXYTETRACYCLINE) WAS PLACED IN THE MIDDLE NASAL PASSAGES. IN THE POST-OPERATIVE PERIOD, THE PATIENT PRESENTED SWELLING ON THE MEDIAL SIDE OF THE RIGHT LOWER EYELID TREATED WITHORAL ANTIBIOTICS AND CORTICOSTEROIDS, DISCRETE MUCOSAL PROLAPSE AT THE LEVEL OF THE RIGHT MAXILLARY SINUS, HAEMATOMA IN THE RIGHT LOWER EYELID, PRONOUNCED INFLAMMATORY TISSUE SWELLING AND GRANULATION TISSUE AROUND THE INSERTED PDS FILM AND SIGNS OF PRESEPTAL OEDEMA AND/OR CELLULITIS IN THE RIGHT EYELIDS, LARGE AMOUNT OF SCAR TISSUE IN ALL LAYERS FROM THE DERMIS INTO THE ORBIT AND RESECTED UNTIL HEALTHY ORBITAL FAT AND GRANULOMAS WITH NUMEROUS MULTINUCLEATED GIANT CELLS IN A DENSE INFLAMMATORY CELL INFILTRATE OF LYMPHOCYTES AND LIPID VACUOLES. THE SWELLING RECUR
Patient problems: Cellulitis; Granuloma; Hematoma; Prolapse; Scar Tissue; Swelling/ Edema
MAUDE report 12986050 ↗
Other SPLINT, INTRANASAL SEPTAL devices
- Nasopore 5400030008Stryker Corporation · SPLINT, INTRANASAL SEPTAL2 recalls1 report
- Nasopore 5400010008Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall4 reports
- Nasopore 5400020108Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Hemopore 5400020208Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall3 reports
- Nasopore 5400222004SStryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400010004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400020004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
- Nasopore 5400030004Stryker Corporation · SPLINT, INTRANASAL SEPTAL1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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