N/A (REF 375-564-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885825014360), received between Mar 21, 2017 and Mar 21, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K012635); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 21, 2017Material Fragmentation

  IT WAS REPORTED THE BLADE OF AN ARTHROSCOPIC SHAVER SHATTERED INSIDE THE PATIENT AND PIECES SCATTERED THROUGHOUT THE SITE. THE PIECES WERE REMOVED USING GRASPERS AND THE DEVICE WAS REPLACED, LEADING TO A DELAY OF 10 MINUTES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6421381 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012635. One submission often covers many models, so check the product and lot details in each record.

• Z-0958-2012 · Jan 26, 2009 · Terminated
  ***CAT 275-534-000***STRYKER***Arthroscopic Blade***3.5mm AGGRESSIVE PLUS***Yellow/Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakelan
• Z-0955-2012 · Jan 26, 2009 · Terminated
  ***CAT 275-941-000***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR Hollow 6 Flute***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakela
• Z-0957-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Hub Style - Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCA
• Z-0961-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lak
• Z-0959-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-532-000***STRYKER***Arthroscopic Blade***3.5mm RESECTOR***Hub Style - Formula***Yellow/Black***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOL
• Z-0956-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-545-000***STRYKER***Arthroscopic Blade***4.0mm TOMCAT CUTTER***Hub Style - Formula***Red/White***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE S
• Z-0954-2012 · Jan 26, 2009 · Terminated
  ***CAT 275-542-000***STRYKER***Arthroscopic Blade***4.0mm RESECTOR***Red***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot nu
• Z-0960-2012 · Jan 26, 2009 · Terminated
  ***CAT 375-941-000***STRYKER***Arthroscopic Bur***4.0mm BARREL BUR***Hollow 6 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakel