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U.S. Department of Health and Human Services

Class 2 Device Recall Tiger Cannulated Screw System

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  Class 2 Device Recall Tiger Cannulated Screw System see related information
Date Initiated by Firm December 08, 2016
Date Posted January 06, 2017
Recall Status1 Terminated 3 on May 17, 2017
Recall Number Z-0960-2017
Recall Event ID 76029
510(K)Number K153338  
Product Classification Screw, fixation, bone - Product Code HWC
Product Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O
The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
Code Information Lot: TSL003191, TSL003637, TSL004101, TSL004395
Recalling Firm/
Trilliant Surgical Ltd.
6721 Portwest Dr Ste 160
Houston TX 77024-8019
For Additional Information Contact Scott Bishop
Manufacturer Reason
for Recall
Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
FDA Determined
Cause 2
Under Investigation by firm
Action Trilliant Surgical Ltd. sent an Urgent Medical Device Recall letter dated December 8, 2016, to all affected consignees. The letter instructed the consignees to 1) identify any/all affected product; 2) document any/all identified product via a provided response form and return to Trilliant Surgical; 3) exchange product upon receipt of replacements; and 4) return any/all affected product as originally identified and reported on the return response form. Customers with questions were instructed to call 800-495-2919.
Quantity in Commerce 50 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