Class 2 Device Recall Brasseler USA, KWIRE, Double Trocar Smooth

• Date Initiated by Firm: January 28, 2022
• Create Date: March 01, 2022
• Recall Status: Terminated on February 03, 2023
• Recall Number: Z-0707-2022
• Recall Event ID: 89555
• 510(K)Number: K945670
• Product Classification: Pin, fixation, smooth - Product Code HTY
• Product: Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
• Code Information: UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX
• Recalling Firm/ Manufacturer: Brasseler USA, Medical L.L.C.; 1 Brasseler Blvd; Savannah GA 31419-9576
• For Additional Information Contact: Sarah DeWeese; 912-925-8525 Ext. 7061
• Manufacturer Reason for Recall: One lot of product was distributed in unsealed packaging
• FDA Determined Cause: Under Investigation by firm
• Action: The firm initiated the recall by telephone on 01/28/2022 and followed with a letter delivered by email. The letter explained the issue and requested the consignee set the affected product aside to be returned to the recalling firm.
• Quantity in Commerce: 231 units
• Distribution: US Nationwide distribution in the states of OH, MI, AZ, FL, CA, TN, TX, SC, PA IL, ID.
• 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