DRI-LOK 3910075800Recalls & reported problems
Stryker Corporation · [Threaded Cannula. Do not resterilize, Do not use if package is damaged] · Class 1
All models of DRI-LOK (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327055726), received between Jan 7, 2019 and Oct 30, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Crack” (4 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Crack4
- Device Contaminated During Manufacture or Shipping1
- Expiration Date Error1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL FOUND INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570941 ↗MalfunctionAug 14, 2024Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT BEING USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19988347 ↗MalfunctionMay 1, 2019Crack
PLEASE NOTE THAT THE INITIAL REPORT'S TYPE OF REPORTABLE EVENT WAS MALFUNCTION. PER INVESTIGATION RESULTS, THE DEVICE WAS NOT CRACKED, THE TIP OF THE CANNULA HAD A DEFORMATION. THE TIP HAVING A DEFORMATION MAY CAUSE USER INCONVENIENCE BUT IS NOT LIKELY TO RESULT IN ANY SAFETY CONCERNS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTS OF MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES. THIS SHOULD NOT RESULT IN ANY ADVERSE CONSEQUENCES IF IT WERE TO RECUR. THEREFORE MAKING THIS EVENT NOT REPORTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8571414 ↗MalfunctionApr 30, 2019Crack
IT WAS REPORTED THAT THE PRODUCT CRACKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8566744 ↗MalfunctionJan 7, 2019Crack
IT WAS REPORTED THAT THE DEVICE WAS CRACKING DURING THE PROCEDURE. A REPLACEMENT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8224568 ↗MalfunctionJan 7, 2019Crack
IT WAS REPORTED THAT THE DEVICE WAS CRACKING DURING THE PROCEDURE. A REPLACEMENT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8224371 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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