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Class 2 Device Recall Trilliant Surgical Ltd TwoStep Hammertoe Implant System |
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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
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Product Classification |
Screw, fixation, bone - Product Code HWC
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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/ Manufacturer |
Trilliant Surgical, LLC 727 N Shepherd Dr Ste 100 Houston TX 77007-1320
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For Additional Information Contact |
Ms. Meagan Olson 800-495-2919 Ext. 1007
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = TRILLIANT SURGICAL LTD
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