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U.S. Department of Health and Human Services

Class 2 Device Recall Trilliant Surgical Ltd TwoStep Hammertoe Implant System

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  Class 2 Device Recall Trilliant Surgical Ltd TwoStep Hammertoe Implant System see related information
Date Initiated by Firm July 19, 2018
Create Date March 30, 2020
Recall Status1 Terminated 3
Recall Number Z-1610-2020
Recall Event ID 84977
510(K)Number K122959  
Product Classification Screw, fixation, bone - Product Code HWC
Product Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
Code Information IFUs previous to Document #900-01-008 Rev. N and Cleaning and Sterilization Protocols previous to Document #900-06-016 Rev. C.
Recalling Firm/
Trilliant Surgical, LLC
727 N Shepherd Dr Ste 100
Houston TX 77007-1320
For Additional Information Contact Ms. Meagan Olson
800-495-2919 Ext. 1007
Manufacturer Reason
for Recall
Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
FDA Determined
Cause 2
Labeling Change Control
Action The recalling firm issued letters as of 7/19/2018 via FedEx.
Quantity in Commerce 17 systems
Distribution Distribution to US states: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY, and PR. There was government distribution and no military distribution. Foreign distribution to Australia, India, Italy, Panama, and Turkey.
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