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U.S. Department of Health and Human Services

Class 2 Device Recall ACL Workstation slider

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 Class 2 Device Recall ACL Workstation slidersee related information
Date Initiated by FirmDecember 07, 2007
Date PostedApril 02, 2008
Recall Status1 Terminated 3 on December 29, 2008
Recall NumberZ-1107-2008
Recall Event ID 46350
510(K)NumberK951267 
Product Classification Arthoscope - Product Code HRX
ProductStryker ACL Workstation slider, Model Number: 234-010-503, Stryker, San Jose, CA 95138
Code Information Lot Numbers: 55-059169, 55-059965, 45165M-3, 44252M-1, and 44660M-1.  
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138
For Additional Information Contact
408-754-2000
Manufacturer 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.
FDA Determined
Cause 2		Component design/selection
ActionOn 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 Commerce142 sliders were distributed.
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HRX
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