Z-1390-05

Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50...

Name: Z-1390-05 Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2005-08-05
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2005-08-05 / Terminated

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A on 2005-08-05. The reason FDA records is "Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1390-05
Status: Terminated
Initiated: 2005-08-05
Posted: 2005-08-23
Terminated: 2005-10-26
Recalling firm: Stryker Corp.
Product: Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.
Product code: DZJ Driver, Wire, And Bone Drill, Manual
Reason for recall: Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
FDA root cause: Other
Action: U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product.
Quantity in commerce: 27
Distribution: Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,
Product codes and lots: All units manufactured June 23, 2005 through July 22, 2005.

Product code DZJ

K040369Class IIStryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments / cleared 2004-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)