N/A 60-7070-105-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH PLC, DUAL PORT, SINGLE BLADDER, 30 IN. (76 CM) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00889024377127), received between Feb 28, 2023 and Nov 11, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. 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
- Delivered as Unsterile Product3
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING PREPARATION FOR THE SURGERY, FOREIGN SUBSTANCES WERE FOUND INSIDE OF THE UNOPENED STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651936 ↗MalfunctionNov 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING PREPARATION FOR THE SURGERY, FOREIGN SUBSTANCES WERE FOUND INSIDE OF THE UNOPENED STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651872 ↗MalfunctionAug 8, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING TESTING, THE STERILE DISPOSABLE BRACELETS COD. 60-7070-10X-00 DO NOT SEEM TO BE CLOSED HERMETICALLY, BECAUSE SQUEEZING THE PACKAGE ALLOWS AIR TO COME OUT. NO DAMAGE TO PACKAGING WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT. DUE DILIGENCE INFORMATION COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19940769 ↗MalfunctionFeb 28, 2023Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE DEVICE WAS NOT INFLATING. NO HARM OR DELAY WERE REPORTED. UPON EVALUATION IT WAS NOTED THAT THE DEVICE WAS LEAKING AIR. NO ADVERSE EVENT WAS REPORTED. DUE DILIGENCE IS COMPLETE. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16452231 ↗
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- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall38 reports
- SmartPump 5920011000Stryker Corporation · TOURNIQUET, PNEUMATIC72 reports
- A.T.S.® Personalized Pressure® 60320010100Zimmer Orthopaedic Surgical Products, Inc. · TOURNIQUET, PNEUMATIC1 recall20 reports
- Color Cuff 5921-034-135NSStryker Corporation · TOURNIQUET, PNEUMATIC1 recall20 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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