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.
FDA Recall Z-0295-2019 · Posted None
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Recalling FirmArthrex, Inc.
Recall StatusOpen, Classified
Product CodeHAB
Date Initiated2018-08-27
Product Quantity335 devices
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.
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 [email protected] as soon as possible to arrange for return of affected product.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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