RePlant® Precision IO Scan Adapter 6035-09PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10841307123934), received between Aug 15, 2018 and Aug 16, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2018Inaccurate Information; Inaccurate Information

  PER INTERNAL COMPLAINT (B)(4), THE FLAT SCAN OF THE SCAN ADAPTER WAS FOUND NOT ALIGNED TO THE TRI-LOBE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7791694 ↗
• MalfunctionAug 16, 2018Nonstandard Device; Nonstandard Device

  PER COMPLAINT (B)(4), THE LOBES ON SCAN BODY OF SCAN ADAPTER DO NOT MATCH UP TO WHAT IS IN THE SOFTWARE ONCE IT IS SCANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787904 ↗
• MalfunctionAug 15, 2018Nonstandard Device; Nonstandard Device

  PER COMPLAINT (B)(4), THE SCAN BODY SENT TO THE LAB WAS ASSEMBLED INCORRECTLY. THE PLASTIC PORTION OF THE SCAN BODY WAS INCORRECTLY ATTACHED TO THE TITANIUM BASE PORTION OF IT. THE FLAT SIDE OF IT IS NOT WHERE IT SHOULD BE. SO, WHEN IT IS SCANNED, IT DOES NOT LINE UP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7787685 ↗