FDA Medical Device Recalls (openFDA)
Stryker Endoscopy: Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
- Recall number
- Z-1107-2008
- Recalling firm
- Stryker Endoscopy
- Product
- Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
- Status
- Terminated
- Initiated
- 2007-12-07
- Posted
- 2008-04-02
- Terminated
- 2008-12-29
- Reason
- Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.
- Root cause
- Component design/selection
- Action
- On January 9, 2008, sales representatives were notified via telephone. All consignees were mailed an Urgent: Device Removal notice, dated January 10, 2008. The firm requested that any affected inventory in stock be quarantined and returned to Stryker Endoscopy for destruction. A response form with return postage was included with notification mailed to all consignees.
- Quantity
- 142 sliders were distributed.
- Distribution
- Worldwide Distribution - including USA states of South Carolina, Oregon, Michigan, Nebraska, Maryland, California, New Mexico, Ohio, Texas, West Virginia, Massachusetts, and Florida and countries of Canada, Mexico, Hong Kong, Argentina, Brazil, France, Germany, Greece, Spain, India, Italy, Columbia, Switzerland, Poland, Sweden, Australia, and Netherlands.
- Lot, serial or model codes
- Lot Numbers: 55-059169, 55-059965, 45165M-3, 44252M-1, and 44660M-1.
- 510(k) numbers
- ["K951267"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 2936485
- Firm city
- San Jose
- Firm state
- CA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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