SPECIALIST 96-6322Recalls & reported problems

Depuy (Ireland) · SPECIALIST 2 TIBIAL CUTTING BLOCK 5 DEG · Class 1

All models of SPECIALIST (80)

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 10603295247869), received between Mar 24, 2023 and Mar 24, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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

Device-Device Incompatibility1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionMar 24, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING THE SURGERY AS THE SURGEON WAS DRILLING THE PINS INTO THE 5 DEGREE TIBIAL CUTTING BLOCK, THE PINS GOT STUCK INTO THE BLOCK. THE SURGEON ASKED IF THE BLOCK WAS DEFECTIVE. THERE WAS A 2 MINUTE DELAY ADDED TO CASE TO RESOLVE THE ISSUE. HE ENDED UP USING A PIN PUSHER AND PLACED THE PINS INTO THE OTHER HOLES ON THE BLOCK.
Patient problems: Insufficient Information
MAUDE report 16610424 ↗

Device details

UDI-DI	`10603295247869`
Brand	SPECIALIST
Model	96-6322
Catalog no.	966322
Company	Depuy (Ireland)
Product code	HTZ · INSTRUMENT, CUTTING, ORTHOPEDIC
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 28, 2026

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.

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All INSTRUMENT, CUTTING, ORTHOPEDIC 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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