A.T.S.® Personalized Pressure® 60-2200-301-13Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Class 1
All models of A.T.S. Personalized Pressure (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024419957), received between Jun 22, 2022 and Jun 22, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Alarm System” (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 18, 2026.
Most reported problems
Device problems
- Device Alarm System2
- Gas/Air Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 22, 2022Device Alarm System; Gas/Air Leak; Device Alarm System; Gas/Air Leak
IT WAS REPORTED AFTER CALIBRATION THE DEVICE ALERTED FOR RESERVOIR LEAKAGE. NO LEAKAGE OR SPONTANEOUS DEFLATION HAD OCCURRED AND NO HARM OR DELAY WERE NOTED. UPON EVALUATION IT WAS NOTED THAT THE TERMINAL CABLE WAS FRAYED. NO OTHER ADVERSE EVENTS WERE REPORTED AS IT RELATES TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14777511 ↗MalfunctionJun 22, 2022Device Alarm System; Gas/Air Leak; Device Alarm System; Gas/Air Leak
IT WAS REPORTED HE DEVICE ALERTED FOR RESERVOIR LEAKAGE. NO LEAKAGE OR SPONTANEOUS DEFLATION HAD OCCURRED AND NO HARM OR DELAY WERE NOTED. UPON EVALUATION IT WAS NOTED THAT THE TERMINAL CABLE WAS FRAYED. NO OTHER ADVERSE EVENTS WERE REPORTED AS IT RELATES TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14777476 ↗
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- Color Cuff 5921018235Stryker Corporation · TOURNIQUET, PNEUMATIC2 recalls20 reports
- 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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