NA E-FP-DIRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845384011750), received between Nov 28, 2017 and Jan 11, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

35 other recalls cover devices cleared under the same FDA submission (K080802); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 11, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FOOT CONTROL DEVICE HAD EXPOSED WIRES. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7182561 ↗
• MalfunctionDec 18, 2017Cut In Material; Cut In Material

  IT WAS REPORTED THAT DURING CLEANING, IT WAS OBSERVED THAT THE FOOT PEDAL DEVICE CORD WAS FRAYED AND THE WIRES WERE EXPOSED. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7126126 ↗
• MalfunctionNov 28, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FOOT CONTROL DEVICE HAD WIRES EXPOSED. IT WAS NOT REPORTED WHETHER THIS EVENT OCCURRED DURING SURGERY OR WHETHER A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7065013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080802. One submission often covers many models, so check the product and lot details in each record.

• Z-2015-2017 · Oct 6, 2016 · Terminated
  Sagittal Saw Product Usage: Pneumatic system
• Z-1948-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction Switch Product Usage: Electric system
• Z-1955-2017 · Oct 6, 2016 · Terminated
  Console, eMax2 Plus Product Usage: Electric system
• Z-2019-2017 · Oct 6, 2016 · Terminated
  Oscillating MICRO-SAW Product Usage: Pneumatic system
• Z-2026-2017 · Oct 6, 2016 · Terminated
  Reciprocating MICRO SAW
• Z-2032-2017 · Oct 6, 2016 · Terminated
  20.2cm Heavy Duty Long Heavy Short Attachment
• Z-1949-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
• Z-1956-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, with irrigation Product Usage: Electric system
• Z-2001-2017 · Oct 6, 2016 · Terminated
  12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
• Z-1957-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, no irrigation
• Z-2031-2017 · Oct 6, 2016 · Terminated
  Sagittal MICRO-SAW
• Z-1952-2017 · Oct 6, 2016 · Terminated
  eMax2 PLUS Product Usage: Electric system
• Z-0728-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine
• Z-0729-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and
• Z-0726-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 1

…and 20 more.