Stryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
FDA Recall Z-1107-2008 · Posted 2008-04-02
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Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHRX
Date Initiated2007-12-07
Date Terminated2008-12-29
Product Quantity142 sliders were distributed.
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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