Medline ReNewal REP110716Recalls & reported problems
Medline Industries, Inc. · 35ULT-ST-ZZ ULTRACUT DUAL PURPOSE BLADE · Class 2
All models of Medline ReNewal (18)
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 10888277354586), received between Nov 8, 2016 and Nov 8, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2016Use of Device Problem; Use of Device Problem
MEDLINE RENEWAL RECEIVED A REPORT INDICATING THAT THE TIP OF THE REPROCESSED LINVATEC ULTRACUTDUAL PURPOSE BLADE, MODEL 35ULT-ST-ZZ, DETACHED DURING A SURGICAL PROCEDURE AND WAS RETRIEVED BY THE SURGEON. THE CUSTOMER STATED THAT ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE, THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6088196 ↗
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- MITEK 242018Medos International Sàrl · Arthroscope731 reports
- METRx® System 9560100Medtronic Sofamor Danek, Inc. · Arthroscope667 reports
- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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.
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