InterActive® Precision IO Scan Adapter 6530-09PTRecalls & reported problems
Implant Direct Sybron Manufacturing LLC · 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 10841307123460), received between Dec 7, 2018 and Dec 7, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Manufacturing, Packaging or Shipping Problem1
- Mechanical Problem1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2018Mechanical Problem; Component Missing; Manufacturing, Packaging or Shipping Problem; Mechanical Problem; Component Missing; Manufacturing, Packaging or Shipping Problem
INTERNAL COMPLAINT- CLAIMS (B)(4) WERE ISSUED FOR PART NUMBER 6534-09PT. THE "INVESITGATION" EXPANDED TO PART NUMBER 6530-09PT. INSPECTION ORDER AND IT WAS FOUND TO HAVE MISSING "FEATURS" AND OUTSIDE OF DIAMETER. LOT CHECK DETERMINED THE ISSUED MACHINED PART NUMBER 6530-81PN-M, LOT NUMBER 100780, WAS USED IN FOUR DIFFERENT FINISHED GOODS LOT NUMBERS, 104151, 106478, 114914 AND 124072. THERE IS NO REMAINING INVENTORY FOR ALL 4 LOTS.
Patient problems: No Patient Involvement
MAUDE report 8143254 ↗
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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 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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