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U.S. Department of Health and Human Services

Class 2 Device Recall 7, 9, and 11Hole VL Gridlock Fibula Plating System

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  Class 2 Device Recall 7, 9, and 11Hole VL Gridlock Fibula Plating System see related information
Date Initiated by Firm August 06, 2015
Date Posted August 31, 2015
Recall Status1 Terminated 3 on January 26, 2017
Recall Number Z-2490-2015
Recall Event ID 71967
510(K)Number K121452  
Product Classification Plate, fixation, bone - Product Code HRS
Product 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.
Code Information Lots: TSL002595, TSL002596, TSL002597
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		 The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating locking screws.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Trilliant Surgical sent an Urgent Medical Device Recall letter dated August 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed and confirmed consignees to discontinue use of the affected lots, quarantine, and return product (if not yet done so) in accordance with an included acknowledgement sheet. For further questions, please call 1(800) 495-2919 , 8:00am - 5:00pm CST
Quantity in Commerce 28 units
Distribution US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
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 = HRS and Original Applicant = TRILLIANT SURGICAL LTD
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