NA SHD-1504TD-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845384015741), received between Mar 11, 2019 and Mar 11, 2019 — classified as 2 malfunctions.

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

39 other recalls cover devices cleared under the same FDA submission (K113476); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2019Fracture; Fracture

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT TWO CUTTING BURRS HAD AN ISSUE BEING LOADED INTO THE HANDPIECE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS OBSERVED THAT THE TIP OF THE CUTTER WAS BROKEN. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. 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 8409734 ↗
• MalfunctionMar 11, 2019Fracture; Fracture

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED THAT TWO CUTTING BURR DEVICES HAD AN ISSUE BEING LOADED INTO THE HANDPIECE DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS OBSERVED THAT THE TIP OF THE CUTTING BURR DEVICE WAS BROKEN. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED. 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 8409728 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113476. One submission often covers many models, so check the product and lot details in each record.

• Z-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
• Z-2840-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
• Z-2838-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
• Z-2295-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone including spine and cranium.
• Z-2285-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2283-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2298-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bone including spine and cranium.
• Z-2310-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone including spine and cranium.
• Z-2282-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium.
• Z-2290-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
• Z-2304-2015 · Apr 13, 2015 · Terminated
  ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting shaping bone including spine and cranium.
• Z-2289-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
• Z-2296-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine and cranium.
• Z-2301-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine and cranium.

…and 24 more.