FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.
- Recall number
- Z-1389-05
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.
- Status
- Terminated
- Initiated
- 2005-08-05
- Posted
- 2005-08-23
- Terminated
- 2005-10-26
- Reason
- Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
- 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
- 25
- Distribution
- Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,
- Lot, serial or model codes
- All units manufactured July 22, 2005 through July 25, 2005.
- 510(k) numbers
- ["K040369"]
- PMA numbers
- not on file
- Product code
- DZJ
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28