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U.S. Department of Health and Human Services

Class 2 Device Recall Battery Housing for AR400

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  Class 2 Device Recall Battery Housing for AR400 see related information
Date Initiated by Firm August 27, 2018
Create Date October 30, 2018
Recall Status1 Open3, Classified
Recall Number Z-0295-2019
Recall Event ID 81106
Product Classification Saw, powered, and accessories - Product Code HAB
Product Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System

Product Usage:
The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
Code Information UDI Number 0888867223349; Material Number AR-400UBH;   Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information Contact
800-933-7001
Manufacturer Reason
for Recall		 The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
FDA Determined
Cause 2		 Under Investigation by firm
Action Arthrex notified customers on or about 08/27/2018 via recall letter entitled "URGENT: VOLUNTARY PRODUCT RECALL NOTIFICATION." The recall letter instructed customers to immediately discontinue use, sale and distribution of the affected product and contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com as soon as possible to arrange for return of affected product.
Quantity in Commerce 335 devices
Distribution Worldwide - Nationwide Distribution in the states of AL, CA, CO, FL, ID, IL, MA, MD, MI, MO, NC, NE, NY, PA, SC, TN, TX, UT, WI. and the countries of Austria, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Kuwait, Lithuania, Netherlands, Norway, Poland, Russia, Slovakia, Spain and Switzerland.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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