BandLoc DUO 10-1102-1555Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841132150627), received between Feb 10, 2020 and Feb 10, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K161267, K200097); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  A SET SCREW DISENGAGED FROM THE BAND-LOC DEVICE. EVENT WAS IDENTIFIED IN POST-OPERATIVE X-RAY. A REVISION SURGERY WAS NOT PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 9690263 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161267, K200097. One submission often covers many models, so check the product and lot details in each record.

• Z-2321-2017 · Apr 24, 2017 · Terminated
  Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in pl