Recall Z-1107-2008 ยท HRX Arthroscope
Stryker Endoscopy
Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
| Date | Apr 2, 2008 (initiated Dec 7, 2007) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951267 | STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM Stryker Endoscopy, Sep 1, 1995 |