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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulated Screw Countersink

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  Class 2 Device Recall Cannulated Screw Countersink see related information
Date Initiated by Firm July 20, 2015
Date Posted August 19, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-2421-2015
Recall Event ID 71783
510(K)Number K081510  
Product Classification Screw, fixation, bone - Product Code HWC
Product 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE


Product Usage:
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 numbers 1362-01 and 1364-01
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 cutting efficiency of the Countersinks was out of specification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Trilliant sent an Important Medical Device Advisory Notice letter dated February 15, 2013 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers of the option to exchange affected instruments at no charge. To initiate the exchange customers were instructed to contact your local Trilliant Surgical Sales Representative, contact the Customer Service Department directly at 1-800-495-2919, or via email at orders@trilliantsurgical.com.
Quantity in Commerce 102 units
Distribution US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD.
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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