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U.S. Department of Health and Human Services

Class 2 Device Recall Tray Lid

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  Class 2 Device Recall Tray Lid see related information
Date Initiated by Firm July 20, 2015
Date Posted August 26, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-2464-2015
Recall Event ID 71813
510(K)Number K081510  K112737  
Product Classification Screw, fixation, bone - Product Code HWC
Product Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System
The Tiger Cannulated Screw Fixation System and the Tiger Headless Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Code Information Lot Numbers ALU120514552473 and 45479
Recalling Firm/
Manufacturer		 Trilliant Surgical Ltd.
6721 Portwest Dr Ste 160
Houston TX 77024-8019
For Additional Information Contact Customer Service
800-495-2919
Manufacturer Reason
for Recall		 Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
FDA Determined
Cause 2		 Component design/selection
Action Trilliant sent an Important Medical Device Adivsory Notice dated November 6, 2013, to all affected customers. The letter instructed customers that they have the option of exchanging affected instruments for trays that meet specification at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical sales representative or the Customer Service Department directly at 1-800-495-2919, or via email at orders@trilliantsurgical.com.
Quantity in Commerce 71 units
Distribution Nationwide Distribution
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 = HWC and Original Applicant = TRILLIANT SURGICAL LTD
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