NA 0210012000Recalls & reported problems
Stryker Corporation · Soft Tissue Tip · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540144171), received between Mar 6, 2019 and Oct 22, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH.2 EVENTS HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 20504461 ↗MalfunctionJul 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH.3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19823232 ↗MalfunctionOct 23, 2023Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES 0 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17986210 ↗MalfunctionMar 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT THE END TIP OF THE IRRIGATOR BROKE DURING A PROCEDURE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8395536 ↗
Other LAVAGE, JET devices
- Elefant ASP185Coloplast A/S · LAVAGE, JET260 reports
- PULSAVAC® 00-5150-475-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET255 reports
- PULSAVAC® 00-5150-482-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET197 reports
- PULSAVAC® 00-5150-475-00Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET164 reports
- Versajet 66800039Smith & Nephew Medical Limited · Lavage, Jet160 reports
- PULSAVAC® 00-5150-482-01Zimmer Orthopaedic Surgical Products, Inc. · LAVAGE, JET154 reports
- Surgiphor 910110Carefusion 2200, Inc · LAVAGE, JET140 reports
- Axius Blower/Mister CB-1000Maquet Cardiovascular LLC · Lavage, Jet1 recall43 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.