NA 4721Recalls & reported problems
Stryker Corporation · STRYKER 2-0 KNOT PUSHER/SUTURE CUTTER AND SLOTTED CANNULA SET · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327364699), received between Jun 18, 2018 and Mar 4, 2026 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping2
- Packaging Problem2
- Delivered as Unsterile Product1
- Device Contamination with Chemical or Other Material1
- Device Operates Differently Than Expected1
- Insufficient Device Problem Information1
- Nonstandard Device1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information3
- Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 4, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A BLACK FOREIGN MATERIAL WAS FOUND INSIDE THE POUCH OF THE DISPOSABLE SUTURE CUTTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24509757 ↗MalfunctionDec 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS A BLACK FOREIGN SUBSTANCE BEFORE OPENING, SO THE PACKAGE WAS NOT OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23883053 ↗MalfunctionSep 28, 2022Packaging Problem; Delivered as Unsterile Product; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15496799 ↗InjuryNov 22, 2021Nonstandard Device; Insufficient Device Problem Information; Nonstandard Device
IT WAS REPORTED THAT THE PLANNED MENISCUS REPAIR WAS ABORTED AND THE SURGEON OPTED FOR A MENISCECTOMY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12857922 ↗MalfunctionOct 20, 2020Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10706178 ↗InjuryJun 18, 2018Use of Device Problem; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE PRODUCT CUT THE PATIENTS SKIN.
Patient problems: Injury
MAUDE report 7612078 ↗
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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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