Class 2 Device Recall HTR Implant System;Trilliant Surgical KWires

• Date Initiated by Firm: November 04, 2019
• Date Posted: April 01, 2020
• Recall Status: Terminated on April 28, 2021
• Recall Number: Z-1635-2020
• Recall Event ID: 84987
• 510(K)Number: K121008
• Product Classification: Pin, fixation, smooth - Product Code HTY
• Product: 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225; (10)TSL007202
• Code Information: Part Number: 220-08-003, Lot Number: TSL007202;Expiration Date: 12/25/2023.
• Recalling Firm/ Manufacturer: Trilliant Surgical, LLC; 727 N Shepherd Dr Ste 100; Houston TX 77007-1320
• For Additional Information Contact: Meagan Olson; 713-388-6066
• Manufacturer Reason for Recall: The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.
• FDA Determined Cause: Mixed-up of materials/components
• Action: The recall strategy included sending complete recall communication and response forms as of 11/04/2019 via FedEx (Express Standard Overnight) to all consignees that showed possession / had been sold a device as of 10/30/2019. The recall communication included the following actions to be taken by the distributor/customer: 1. Check inventory stock for the identified device. 2. Open the shipper box* on the end opposite of the label and remove the internal packaging. *Note: Opening the shipper box does not disrupt the sterile barrier. The double sterile barrier is maintained within the internal packaging. 3. Through the transparent internal packaging, verify that the kit contains the appropriate quantity and type of each reamer; (1) Concave Reamer and (1) Convex Reamer. If product in possession IS identified as affected by containing (2) of the same reamer type, quarantine and/or discontinue use of the device and return the affected device(s) to the firm in accordance with the included Return Response (Acknowledgment and Receipt Form). If product in possession IS NOT affected (i.e. there is 1 Concave Reamer and 1 Convex Reamer within the packaging, complete and return the included Return Response (Acknowledgment and Receipt Form). THE INCLUDED RETURN RESPONSE IS REQUIRED EVEN IF AFFECTED PRODUCT IS NOT IDENTIFIED. For questions regarding the communication, the phone number is 800.495.2919.
• Quantity in Commerce: 117
• Distribution: Distributors in 21 states: AR, AZ, CA, FL, GA, IA,IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI.
• 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 = HTY and Original Applicant = TRILLIANT SURGICAL LTD