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U.S. Department of Health and Human Services

Class 2 Device Recall Tiger Large Cannulated Headless Screw System

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  Class 2 Device Recall Tiger Large Cannulated Headless Screw System see related information
Date Initiated by Firm September 02, 2016
Date Posted November 17, 2016
Recall Status1 Terminated 3 on May 19, 2017
Recall Number Z-0609-2017
Recall Event ID 75187
510(K)Number K112737  
Product Classification Screw, fixation, bone - Product Code HWC
Product Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
Code Information Lot TSL003721
Recalling Firm/
Trilliant Surgical Ltd.
6721 Portwest Dr Ste 160
Houston TX 77024-8019
For Additional Information Contact Krystal Johnson
Manufacturer Reason
for Recall
Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.
FDA Determined
Cause 2
Nonconforming Material/Component
Action The firm sent out written notifcation of the recall on 9/2/16; the letter instructed the consignees to discontinue use of the affected lot, quarantine, and return product of the affected lot in accordance with an included acknowledgement sheet.
Quantity in Commerce 11
Distribution CA, AZ, WI, FL, NJ, OH
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