Integra® RET-920-60Recalls & reported problems
Ascension Orthopedics, Inc. · Integra®Surgical Instruments The Kolbel retractor frame is the base of the retractor, in which different size blades are attached. The retractor is used to withdraw muscle and tissue for exposure. · Class 1
Data updated Oct 13, 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 10381780246930), received between May 23, 2022 and May 23, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
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.
MalfunctionMay 23, 2022Break; Break
IT WAS REPORTED THAT, A SCREW OF THE KOLBEL RETRACTOR FRAME FELL OUT OF MIDDLE OF RETRACTOR MAKING IT UNUSABLE. IT IS UNKNOWN WHEN THE EVENT HAPPENED OR IF THERE WAS ANY DELAY OR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE AND HOW THE ISSUE WAS SOLVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14480518 ↗
Other RETRACTOR devices
- Endo Paddle Retract 173046Covidien LP · RETRACTOR56 reports
- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- Omni-Tract® 11275Integra Lifesciences Corporation · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 10269Integra Lifesciences Corporation · RETRACTOR1 recall0 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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