Class 2 Device Recall KLSBP001 Battery Pack

• Date Initiated by Firm: December 23, 2015
• Date Posted: March 11, 2016
• Recall Status: Terminated on July 21, 2017
• Recall Number: Z-1095-2016
• Recall Event ID: 73034
• Product Classification: Battery, replacement, rechargeable - Product Code MOQ
• Product: Battery Pack; KLS-SD-1000; Single; Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).
• Code Information: Lots 509567, K055R
• Recalling Firm/ Manufacturer: Pro-Dex Inc; 2361 McGaw Ave; Irvine CA 92614-5831
• For Additional Information Contact: 800-562-6204
• Manufacturer Reason for Recall: The sterile battery may contain particulates within the sterile package.
• FDA Determined Cause: Process change control
• Action: A customer notification letter was sent 12/23/15. The letter instructs the customer to cease distribution and use of the recalled lots. It also recommends that the inventory and distribution records be evaluated immediately to ensure that affected product is removed from any potential point of use. Return product to: Returns Department (Recall complaint ClS-001) Pro-Dex, Inc 2361 McGaw Avenue Irvine, California 92614 USA Reference the Recall Complaint # on the outside of the shipping box. If any questions or concerns, please contact the QARA group at Pro-Dex at 949 769 3200.
• Quantity in Commerce: 1995 total
• Distribution: Distributed in FL.
• 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.