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U.S. Department of Health and Human Services

Class 2 Device Recall PRODEX Surgical Driver Battery Pack

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  Class 2 Device Recall PRODEX Surgical Driver Battery Pack see related information
Date Initiated by Firm September 25, 2018
Create Date August 22, 2019
Recall Status1 Terminated 3 on April 20, 2022
Recall Number Z-2340-2019
Recall Event ID 83113
Product Classification Motor, surgical instrument, ac-powered - Product Code GEY
Product PRO-DEX Surgical Driver Battery Pack PDBP-001 Series
PRO-DEX Battery Pack, Single Pouch - PDBP-001-2
PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2

Product Usage:
-The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.
Code Information PDBP-001 Series Model: PDBP-040-2 (40ct PDBP-001-2) which are 40 count batteries. Lot(s): K098N (61900), K0B3F (62625)  K098N and K0B3F are Pro-Dex lot numbers. 61900 and 62625 are the contract packager's lot numbers  UDI Code: (01) 0 0860540 00025 6
Recalling Firm/
Manufacturer		 Pro-Dex Inc
2361 McGaw Ave
Irvine CA 92614-5831
For Additional Information Contact Steven Pavlik
800-562-6204
Manufacturer Reason
for Recall		 Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 09/25/2018, the firm sent an "URGENT" notification to customers via email and followed up with a (USPS) letter on 09/26/2018 informing them that certain lots of sterile batteries may have visible particulates within the battery Tyvek pouch. Customers were advised to 1) "immediately cease distribution and use of these lots, and 2) Inventory and distribution records should be evaluated immediately to ensure that affected product is removed from any potential point of use". Customers are instructed to return products to: Returns Department (Recall complaint C18-061 Pro-Dex, Inc. 2361 McGaw Avenue Irvine, CA 92614 USA and to reference the Recall Complaint #C18-061 on the outside of the shipping box. If the customers have any questions or concerns to contact the QARA group at 949 769 3200.
Quantity in Commerce 68 cases of 40 batteries = 2,720 individual batteries
Distribution Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.
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.
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