T2 1806-9950Recalls & reported problems
Stryker GmbH · Instrument Tray · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540605894), received between Feb 4, 2025 and Feb 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Clean Adequately” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Clean Adequately1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2025Failure to Clean Adequately; Failure to Clean Adequately
AS REPORTED: "THE INSTRUMENTS WAS CLEANED AND STERILIZED AT THE HOSPITAL ON THE DAY BEFORE SURGERY, A STAIN WAS FOUND ON THE CLOTH THAT WRAPPED THE INSTRUMENT TRAY. THE STERILIZATION WAS DETERMINED TO BE INADEQUATE, AND CLEANING AND STERILIZATION WERE PERFORMED AGAIN, BUT THE SAME PHENOMENON OCCURRED THE SECOND TIME. FINALLY, ON THE DAY OF SURGERY, ALL INSTRUMENT PARTS WERE REMOVED FROM THE INSTRUMENT TRAY AND INDIVIDUALLY CLEANED AND STERILIZED. THIS DELAYED THE PATIENT'S ENTRY INTO THE OPERATING ROOM, WHICH WAS SCHEDULED FOR 12:00 P.M., BY MORE THAN THREE HOURS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21304120 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page