Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ACL Workstation slider

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ACL Workstation slider see related information
Date Initiated by Firm December 07, 2007
Date Posted April 02, 2008
Recall Status1 Terminated 3 on December 29, 2008
Recall Number Z-1107-2008
Recall Event ID 46350
510(K)Number K951267  
Product Classification Arthoscope - Product Code HRX
Product Stryker 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HRX and Original Applicant = Stryker Endoscopy
-
-