AutoPlex 0605887000Recalls & reported problems

Stryker Corporation · System without Needles and Cement · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

Nov 9, 2017Terminated
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Z-1250-2018 · Root cause: Environmental control · Recall details · FDA record ↗

Device details

UDI-DI	`04546540593108`
Brand	AutoPlex
Model	0605887000
Company	Stryker Corporation
Product code	JDZ · MIXER, CEMENT, FOR CLINICAL USE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 25, 2018

Device type (GMDN): Orthopaedic cement preparation/delivery kit

A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.

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All MIXER, CEMENT, FOR CLINICAL USE 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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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