NA SC2102Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845384011989), received between May 15, 2025 and May 15, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Complete Loss of Power” (1 report).

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

• MalfunctionMay 15, 2025Device Alarm System; Noise, Audible; Complete Loss of Power; Device Alarm System; Noise, Audible; Complete Loss of Power

  IT WAS REPORTED THAT THE SYSTEM CONSOLE DEVICE WAS NOT WORKING PROPERLY AND WOULD ONLY MAKE A CLICKING NOISE WHEN IN USE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE DEVICE WAS DISPLAYING AN E8 ERROR CODE (SYSTEM FAULT), AN ERRONEOUS ERROR CODE, AND HAD COMPONENT DAMAGE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR POWER CORD. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22027675 ↗

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-2031-2017 · Oct 6, 2016 · Terminated
  Sagittal MICRO-SAW
• Z-2019-2017 · Oct 6, 2016 · Terminated
  Oscillating MICRO-SAW Product Usage: Pneumatic system
• Z-1957-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, no irrigation
• Z-1955-2017 · Oct 6, 2016 · Terminated
  Console, eMax2 Plus Product Usage: Electric system
• Z-1956-2017 · Oct 6, 2016 · Terminated
  System Console, Single Port, with irrigation Product Usage: Electric system
• Z-1949-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
• Z-2026-2017 · Oct 6, 2016 · Terminated
  Reciprocating MICRO SAW
• Z-2001-2017 · Oct 6, 2016 · Terminated
  12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
• Z-2032-2017 · Oct 6, 2016 · Terminated
  20.2cm Heavy Duty Long Heavy Short Attachment
• Z-1948-2017 · Oct 6, 2016 · Terminated
  Electronic Foot Control with Direction Switch Product Usage: Electric system
• Z-2015-2017 · Oct 6, 2016 · Terminated
  Sagittal Saw Product Usage: Pneumatic system
• Z-1952-2017 · Oct 6, 2016 · Terminated
  eMax2 PLUS Product Usage: Electric system
• Z-0727-2014 · Dec 17, 2013 · Terminated
  Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM C
• 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

…and 20 more.