Class 2 Device Recall TriMed Hex Cortical Screw

• Date Initiated by Firm: August 24, 2018
• Create Date: April 23, 2019
• Recall Status: Terminated on December 28, 2020
• Recall Number: Z-1214-2019
• Recall Event ID: 82209
• 510(K)Number: K060041
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System.; ; The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.
• Code Information: Lot #170281, UDI (01)00842188107108(11)170406(10)170281
• Recalling Firm/ Manufacturer: TriMed Inc.; 27533 Avenue Hopkins; Santa Clarita CA 91355-3910
• For Additional Information Contact: Ms. Annie Cranston; 661-255-7406
• Manufacturer Reason for Recall: The bone screw is shorter than the intended design specification.
• FDA Determined Cause: Component design/selection
• Action: The recalling firm, TriMed, issued a "URGENT MEDICAL DEVICE RECALL" letter via email on 8/24/2018 to the distributors and third-party distributor. A follow-up letter was issued 3/28/2019 requesting downstream customers be notified to the user level. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " If the customer further distributed Hex Cortical Screws, 4.0mm that is the subject of this recall, to forward the letter and the return response card to those entities that utilized the impacted product. " If the customer utilized the Hex Cortical Screws, 4.0mm that is the subject of this recall, then the customer is to: o Review customer inventory (including any kits that you have prepared for surgical operation) to see if they have any of the impacted product. o If a customer does have impacted product within its inventory, remove the product from use. o Review customer records to see if the impacted product was implanted. If the customer has records that impacted product was implanted, the customer should apply medical judgment to determine whether additional patient monitoring activities should be performed to evaluate implant placement, implant structural integrity, and fracture union. o Return to TriMed a return response card by 11 April 2019. Please email the response to: quality@trimedortho.com. Please contact TriMed via telephone or email as per below if you have any questions: Telephone*: 800-633-7221 or Email: quality@trimedortho.com * Hours of operation: 8:00AM to 5:00PM PST (Monday through Friday, excluding holidays).
• Quantity in Commerce: 13 screws
• Distribution: US Distribution to states of FL and MO.
• 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 = TRIMED, INC.