NA L-1SB-G1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00845384014553), received between Oct 4, 2019 and Oct 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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

• MalfunctionOct 4, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE CUTTER DEVICE BROKE INTO TWO. ACCORDING TO THE REPORTER, BOTH PIECES WERE REMOVED. IT WAS UNKNOWN IF THERE WERE ANY DELAYS IN THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 9157007 ↗

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-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-2837-2016 · Aug 26, 2016 · Terminated
  G1 Dissection Tool - 7mm FBALL L; 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-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-2281-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-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-2290-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
• Z-2306-2015 · Apr 13, 2015 · Terminated
  ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-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-2301-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-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-2302-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-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-2294-2015 · Apr 13, 2015 · Terminated
  ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone including spine and cranium.
• Z-2284-2015 · Apr 13, 2015 · Terminated
  ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.

…and 24 more.