Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
FDA device recall Z-1107-2008 · posted 2008-04-02 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 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 C
- Date initiated
- 2007-12-07
- Date posted
- 2008-04-02
- Date terminated
- 2008-12-29
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM (K951267) | Stryker Endoscopy | 1995-09-01 |