Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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.