CrossBlade 0475561000Recalls & reported problems
Stryker Corporation · Bursector 5.5 mm x 125 mm. Do Not Resterilize, Do Not Use If Package Is Damaged, Keep Dry, Keep Away From Direct Sunlight · Class 1
All models of CrossBlade (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327502619), received between Sep 22, 2023 and Jun 25, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (8 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
- Device Contaminated During Manufacture or Shipping8
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE IS A PIECE OF PLASTIC INSIDE THE PACKAGING. THE PRODUCT HAS NOT BEEN OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25630210 ↗MalfunctionFeb 11, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE SHAVER WAS PACKAGED NON-STERILE DUE TO FOREIGN MATERIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24317592 ↗MalfunctionNov 18, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS THE PRESENCE OF METAL PARTICLES IN THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23587397 ↗MalfunctionFeb 4, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21308649 ↗MalfunctionApr 5, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055524 ↗MalfunctionSep 22, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17802705 ↗MalfunctionSep 22, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17802077 ↗MalfunctionSep 22, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL INSIDE THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17801264 ↗
Other BUR, SURGICAL, GENERAL & PLASTIC SURGERY devices
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- NA 310.21Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY29 reports
- NA 351.27Synthes GmbH · BUR, SURGICAL, GENERAL & PLASTIC SURGERY28 reports
- Arthrex® AR-8500OBEArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY27 reports
- Arthrex® AR-8500FOTArthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY17 reports
- Arthrex® AR-8150PX-45Arthrex, Inc. · BUR, SURGICAL, GENERAL & PLASTIC SURGERY15 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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