ZONE SPECIFIC 8530Recalls & reported problems
Conmed Corporation · ZONE SPECIFIC II MENISCAL REPAIR CANNULA, RIGHT POSTERIOR · Class 1
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 10845854025239), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE 8530, ZONE SPECIFIC II MENISCAL REPAIR CANNULA, RIGHT POSTERIOR DEVICE WAS BEING USED DURING AN ACL RECONSTRUCTION PROCEDURE ON 21JUL24, AND ¿ZONE SPECIFIC II CANNULA BROKEN EASILY DURING SURGERY. SURGEON FOLLOWED THE IFU AND HELD SOFTLY ON THE MENISCUS. SURGEON IS EXPERIENCED IN USING ZONE SPECIFIC.¿ FOLLOW-UP ASSESSMENT FOUND THAT ALL FRAGMENTS OR COMPONENTS WERE RETRIEVED FROM THE SURGICAL SITE USING AN ARTHROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19927541 ↗
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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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