Cortera 1505-000120Recalls & reported problems
Xtant Medical Holdings, Inc. · Handle, Torque Limiting, 90inlb · Class 1
All models of Cortera (7)
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 00840311210756), received between Jun 4, 2026 and Jun 4, 2026 — classified as 1 malfunction.
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
- No Apparent Adverse Event1
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.
MalfunctionJun 4, 2026No Apparent Adverse Event
THE MANUFACTURER WAS MADE AWARE OF TWO 90 IN-LB TORQUE-LIMITING HANDLES THAT WERE REQUESTED TO BE REPLACED AND VERIFIED FOR TORQUE-LIMITING CALIBRATION. THE RETURNED TORQUE LIMITING HANDLES WERE TESTED AND WERE FOUND TO BE WITHIN SPECIFICATION. ADDITIONALLY, AN X-RAY IMAGE WAS PROVIDED WITH THE COMPLAINT; HOWEVER, NO CONTEXT WAS PROVIDED WITH THE IMAGE AND THERE WAS NO IDENTIFYING INFORMATION LINKING THE IMAGE TO THE TORQUE-LIMITING HANDLES. THERE WERE NO REPORTED PATIENT INJURIES OR DELAYS IN SURGERY ASSOCIATED WITH THE COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393493 ↗
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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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