Z-1107-2008
Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
Stryker Corp. / initiated 2007-12-07 / Terminated / root cause: design
Stryker Endoscopy began a recall of Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138 on . The reason FDA records is "Slider Lock Failure - The ACL Workstation slider, a component of the ACL workstation, does not consistently lock into the ACL Workstation Base". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1107-2008
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Stryker Corp.
- Product
- Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
- Product code
- HRX Arthroscope
- 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.
- Root cause tag
- design
- FDA 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 in commerce
- 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.
- Product codes and lots
- Lot Numbers: 55-059169, 55-059965, 45165M-3, 44252M-1, and 44660M-1.
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