Class 2 Device Recall TriMed SemiTubular Plate

• Date Initiated by Firm: August 29, 2016
• Create Date: September 20, 2016
• Recall Status: Terminated on November 01, 2016
• Recall Number: Z-2849-2016
• Recall Event ID: 75080
• 510(K)Number: K060041
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
• Code Information: Lot no. 06206
• Recalling Firm/ Manufacturer: Trimed Inc; 27533 Avenue Hopkins; Santa Clarita CA 91355-3910
• For Additional Information Contact: Teresa Black; 800-633-7221
• Manufacturer Reason for Recall: TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.
• FDA Determined Cause: Device Design
• Action: The firm, TriMed, sent a "Medical Device Recall Notification" Letter dated 8/29/16 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product subject to this recall; notify your customers at once of this product recall; discontinue use; return product, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form as soon as possible by Fax to: 1-661-254-8485 or email to: davidmedoff@trimedortho.com. Customers with questions are instructed to contact Director of Operations at (800) 633-7221, davidmedoff@trimedortho.com, M-F, 9am-5pm, Pacific Standard.
• Quantity in Commerce: 30 units
• Distribution: Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.
• 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