DRI-LOKRecalls & reported problems across all models
Stryker Corporation · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 3 models of DRI-LOK by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 10 adverse event reports in the FDA's MAUDE database, received between Jan 7, 2019 and Oct 30, 2024 — classified as 4 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Crack” (4 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
DRI-LOK recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 21, 2017Class IICompleted
Inadvertent shipment of expired units.
Z-2057-2018 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗
Most reported DRI-LOK problems
Device problems
- Crack4
- Adverse Event Without Identified Device or Use Problem3
- Leak/Splash3
- Device Contaminated During Manufacture or Shipping1
- Expiration Date Error1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient4
- Extravasation3
DRI-LOK models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DRI-LOK 3910090800Accessories, arthroscopic1 recall3 reports
- DRI-LOK 3910075800Accessories, arthroscopic6 reports
- DRI-LOK 3910075650Accessories, arthroscopic1 report
Recent DRI-LOK adverse event reports
The 10 most recent reports across all models, 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 ↗InjuryJun 18, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE DISTAL TIP OF THE DEVICE BROKE DURING THE PROCEDURE AND POTENTIALLY REMAINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563858 ↗InjuryOct 5, 2021Leak/Splash; Leak/Splash; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTRAVASATION.
Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions
MAUDE report 12578304 ↗InjuryOct 5, 2021Leak/Splash; Leak/Splash; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTRAVASATION.
Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions
MAUDE report 12578303 ↗InjuryOct 5, 2021Leak/Splash; Leak/Splash; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTRAVASATION.
Patient problems: Extravasation; No Clinical Signs, Symptoms or Conditions
MAUDE report 12578302 ↗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 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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