Class 2 Device Recall Drill Guides

• Date Initiated by Firm: May 21, 2015
• Date Posted: July 14, 2015
• Recall Status: Terminated on July 16, 2015
• Recall Number: Z-2071-2015
• Recall Event ID: 71501
• 510(K)Number: K143576
• Product Classification: Appliance, fixation, spinal intervertebral body - Product Code KWQ
• Product: Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
• Code Information: Catalog Number 05-109-14-0000, Lot # 68266001.
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Graham L. Cuthbert; 352-377-1140
• Manufacturer Reason for Recall: Shipped to a single consignee prior to completion of final inspection.
• FDA Determined Cause: Release of Material/Component prior to receiving test results
• Action: Exactech contacted their consignee by telephone on May 21, 2015, of this recall for their two products and instructed him to recover the devices from the hospital. Devices were recovered from the hospital May 22, 2015, and returned to the firm on May 26. All devices have been recovered.
• Quantity in Commerce: 2 devices.
• Distribution: Nationwide Distribution to Florida only.
• 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 = KWQ