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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulated Drill Bit

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  Class 2 Device Recall Cannulated Drill Bit see related information
Date Initiated by Firm July 20, 2015
Date Posted August 24, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-2452-2015
Recall Event ID 71812
510(K)Number K081510  
Product Classification Bit, drill - Product Code HTW
Product 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System
The Tiger 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 1363-01
Recalling Firm/
Manufacturer		 Trilliant Surgical Ltd.
6721 Portwest Dr Ste 160
Houston TX 77024-8019
For Additional Information Contact Customer Service Department
800-495-2919
Manufacturer Reason
for Recall		 The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Trilliant Surgical sent an Important Medical Device Advisory Notice to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Customers were instructed they have the option to exchange the affected drill bits at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical Sales Representative or contact the Customer Service Department directly at 1-800-495-2919 or via email at orders@trilliantsurgical.com.
Quantity in Commerce 121 units
Distribution Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.
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 = HTW and Original Applicant = TRILLIANT SURGICAL LTD
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