INSTRUMENT I-K4233KT0LRecalls & reported problems

Howmedica Osteonics Corp. · Specialty Triathlon MIS Tibial Resection Guide Left · Class 1

All models of INSTRUMENT (131)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327503258), received between Jul 29, 2020 and Jul 30, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (4 reports).

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

Device problems

Device Markings/Labelling Problem4

Patient problems

No Clinical Signs, Symptoms or Conditions4
No Known Impact Or Consequence To Patient4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 30, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE CROSS PIN HOLE IS NOT WHERE IT IS SUPPOSED TO BE ON CUSTOM TIBIA CUTTING BLOCKS. ISSUE WAS NOTICED DURING A TKA CASE. REP CONFIRMED THAT THERE WAS NO SURGICAL DELAY AND THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE SURGEON OR HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10343730 ↗
MalfunctionJul 29, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE CROSS PIN HOLE IS NOT WHERE IT IS SUPPOSED TO BE ON CUSTOM TIBIA CUTTING BLOCKS. ISSUE WAS NOTICED DURING A TKA CASE. REP CONFIRMED THAT THERE WAS NO SURGICAL DELAY AND THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE SURGEON OR HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10342053 ↗
MalfunctionJul 29, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE CROSS PIN HOLE IS NOT WHERE IT IS SUPPOSED TO BE ON CUSTOM TIBIA CUTTING BLOCKS. ISSUE WAS NOTICED DURING A TKA CASE. REP CONFIRMED THAT THERE WAS NO SURGICAL DELAY AND THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE SURGEON OR HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10342049 ↗
MalfunctionJul 29, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE CROSS PIN HOLE IS NOT WHERE IT IS SUPPOSED TO BE ON CUSTOM TIBIA CUTTING BLOCKS. ISSUE WAS NOTICED DURING A TKA CASE. REP CONFIRMED THAT THERE WAS NO SURGICAL DELAY AND THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE SURGEON OR HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10340995 ↗

Device details

UDI-DI	`07613327503258`
Brand	INSTRUMENT
Model	I-K4233KT0L
Company	Howmedica Osteonics Corp.
Product code	FZX · Guide, surgical, instrument
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 3, 2023

Device type (GMDN): Orthopaedic prosthesis implantation positioning instrument, reusable

A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Other Guide, surgical, instrument devices

NA 03.037.017
Synthes GmbH · Guide, surgical, instrument
346 reports
EVOS 71174934
Smith & Nephew, Inc. · Guide, surgical, instrument
149 reports
LCP 323.042
Synthes GmbH · Guide, surgical, instrument
129 reports
DJO SURGICAL 342-10-705
Encore Medical, L.P. · Guide, Surgical, Instrument
1 recall51 reports
DJO SURGICAL 341-10-707
Encore Medical, L.P. · Guide, Surgical, Instrument
81 reports
NA 03.010.404
Synthes GmbH · Guide, surgical, instrument
73 reports
DJO SURGICAL 341-14-708
Encore Medical, L.P. · Guide, Surgical, Instrument
1 recall22 reports
DJO SURGICAL 341-10-711
Encore Medical, L.P. · Guide, Surgical, Instrument
1 recall16 reports

All Guide, surgical, instrument devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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