NA L-8NS-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845384012528), received between Jun 14, 2021 and Jun 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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 16, 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.

• MalfunctionJun 30, 2021Dull, Blunt; Separation Problem; Dull, Blunt; Separation Problem

  IT WAS REPORTED BY (B)(6) THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE CUTTER DEVICE FAILED THE VISUAL INSPECTION. IT WAS DETERMINED THAT THE CUTTER WAS STUCK INSIDE THE ATTACHMENT DEVICE AND IT WAS HARD TO INSERT THE CUTTER INTO AN ATTACHMENT, BUT STILL POSSIBLE TO LOCK THE ASSEMBLY INTO A HANDPIECE DEVICE. IT WAS OBSERVED THAT THE CUTTER SHOWED DISCOLORATION, TRACES OF FOREIGN SUBSTANCE AND CORROSION ON ITS SHAFT. THE DIAMETER WAS MEASURED, AND IT WAS DETERMINED THAT IT EXCEEDED THE TOLERANCE OF 0.01MM (MILLIMETER) WHERE THE FOREIGN SUBSTANCE AND DISCOLORATION WAS DETECTED. IT WAS DETERMINED THAT THE CUTTER BLADES SHOWED REGULAR SIGNS OF WEAR. IT WAS NOTED IN THE SERVICE ORDER THAT THE CUTTER DEVICE WAS STUCK IN THE ATTACHMENT DEVICE AND COULD NOT BE RELEASED. THE REPORTER STATED THAT THE CUTTER INFORMATION WAS UNABLE TO BE DETERMINED BECAUSE IT WAS STUCK IN THE ATTACHMENT. THE DEVICES WERE USED TOGETHER WITH THE DRILL DEVICE. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094430 ↗
• MalfunctionJun 14, 2021Dull, Blunt; Separation Problem; Dull, Blunt; Separation Problem

  IT WAS REPORTED THAT THE CUTTER DEVICE WAS STUCK IN THE ATTACHMENT DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS CONFIRMED THAT THE CUTTER DEVICE WAS STUCK IN THE ATTACHMENT DEVICE, HOWEVER IT COULD BE RELEASED. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT. THE DEVICE SHOWED HEAVY SIGNS OF USAGE MOSTLY ALONG THE SHAFT, THE CUTTING EDGE WAS HEAVILY WORN, AND HAD DEBRIS AND DISCOLORATION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY 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 11996114 ↗

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-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; 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-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-2839-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 3mm FLUTED BALL; For cutting and 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-2312-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone including spine and cranium.
• Z-2291-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2309-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone including spine and cranium.
• Z-2305-2015 · Apr 13, 2015 · Terminated
  ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bone including spine and cranium.
• Z-2287-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
• Z-2299-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium.
• Z-2311-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bone including spine and cranium.
• Z-2280-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
• Z-2288-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-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.

…and 24 more.