Class 2 Device Recall Torque Defining Screw and Screwdriver

• Date Initiated by Firm: October 25, 2016
• Create Date: December 22, 2016
• Recall Status: Terminated on July 26, 2019
• Recall Number: Z-0900-2017
• Recall Event ID: 75740
• 510(K)Number: K063569
• Product Classification: Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
• Product: Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
• Code Information: Catalog No. 320-20-00; Unique Device Identifier 10885862086518; Serial Range 4410696-4410819, 4415393-4415492, 4418789-4418888, 4422658-4423007, 4423542-4423591, 4424509-4424558, 4458153-4458252, 4458303-4458352, 4461732-4461806, 4464592-4464691, 4467733-4467824, 4471099-4471298, 4485494-4485543, 4488224-4488260, 4504738-4504987, 4513150-4513199, 4513250-4513299, 4517116-4517215, 4519806-4520005, 4533291-4533390, 4542043-4542092.
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Kaya Davis; 352-377-1140
• Manufacturer Reason for Recall: Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
• FDA Determined Cause: Component design/selection
• Action: Exactech sent an Advisory Notice on October 25, 2016, to Exactech field agents in the U.S. Agents outside of the U.S. were notified on November 2, 2016. Field agents were notified of the recall in the Advisory Notice and asked to notify their accounts that may have the recalled product in stock. Agents were required to complete and return the Field Advisory Notice Response Form within 5 working days. For further questions, please call (352) 377-1140.
• Quantity in Commerce: 2,278 units
• Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of : Austria, Australia, Canada, Germany, France, Spain, India, Switzerland, Italy, South Korea, United Kingdom, Brazil, Luxembourg, Greece, Guatemala, Netherlands, South Africa, and Sweden
• 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 = KWT