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U.S. Department of Health and Human Services

Class 2 Device Recall DARTFIRE CANNULATED DRIVER STAR 8

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  Class 2 Device Recall DARTFIRE CANNULATED DRIVER STAR 8 see related information
Date Initiated by Firm August 26, 2010
Date Posted September 22, 2010
Recall Status1 Terminated 3 on August 02, 2012
Recall Number Z-2470-2010
Recall Event ID 56667
Product Classification Screwdriver - Product Code HXX
Product DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
Code Information Lot number 040754491
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Debbie Daurer
901-867-4601
Manufacturer Reason
for Recall		 After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake.
FDA Determined
Cause 2		 Process design
Action The firm initiated their recall the product by letter on 08/26/2010. The letters were addressed to distributors and hospital administrators with a fax back response form. Please contact Customer Service at 800-238-7117, if you have any questions.
Quantity in Commerce 13 units
Distribution TX, PA, TN, VA, GA, and Spain
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.
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