ZUK 00579102300Recalls & reported problems

Smith & Nephew, Inc. · Medial Distal Femoral Resector · Class 1

All models of ZUK (46)

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556618912), received between Nov 26, 2020 and Nov 26, 2020 — classified as 1 malfunction.

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

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

Illegible Information1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionNov 26, 2020Illegible Information; Illegible Information
IT WAS REPORTED THAT DURING PROCEDURE AND INSIDE THE PATIENT IT WAS NOTICED THAT THE MEDIAL DISTAL FEMORAL RESECTOR HAD TO BE REPLACED DUE TO THE LASER ETCHINGS ARE FADED AND DIFFICULT TO SEE. SURGERY WAS DELAYED FOR NO MORE THAT 30 MIN AND COMPLETED WITH THE SAME DEVICE. NO PATIENT INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10910831 ↗

Device details

UDI-DI	`00885556618912`
Brand	ZUK
Model	00579102300
Company	Smith & Nephew, Inc.
Product code	LXH · ORTHOPEDIC MANUAL 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	Sep 7, 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 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices

AML EXCEL 2001-42-000
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2,009 reports
NA 03.010.523
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EXPRESSEW 214141
Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
1,166 reports
N/A 9560524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
866 reports
INHANCE 6500-11-104
Depuy (Ireland) · Orthopedic manual surgical instrument
831 reports
INHANCE 6500-11-102
Depuy (Ireland) · Orthopedic manual surgical instrument
567 reports
R3 71364450
Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
520 reports
N/A 9561524
Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
494 reports

All ORTHOPEDIC MANUAL 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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