N/A 3925-02Recalls & reported problems

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024067165), received between Jul 7, 2020 and Mar 24, 2025 — classified as 2 malfunctions.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Fracture2

Patient problems

No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 24, 2025Fracture; Fracture
NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21677690 ↗
MalfunctionJul 7, 2020Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10240312 ↗

Device details

UDI-DI	`00889024067165`
Brand	N/A
Model	3925-02
Catalog no.	00-3925-002-00
Company	Zimmer, Inc.
Product code	HXZ · CUTTER, WIRE
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 CUTTER, WIRE devices

NA 03.607.513
Synthes GmbH · CUTTER, WIRE
35 reports
NA 03.221.006
Synthes GmbH · CUTTER, WIRE
34 reports
NA 388.72
Synthes GmbH · CUTTER, WIRE
29 reports
NA 03.221.008
Synthes GmbH · CUTTER, WIRE
11 reports
NA 391.93
Synthes GmbH · CUTTER, WIRE
9 reports
NA 391.771
Synthes GmbH · CUTTER, WIRE
8 reports
NA 391.906
Synthes GmbH · CUTTER, WIRE
8 reports
NA 391.905
Synthes GmbH · CUTTER, WIRE
7 reports

All CUTTER, WIRE 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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