Z-0295-2019Class II

Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System

Name: Z-0295-2019 Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System
Creator: Arthrex, Inc.
Published: 2018-08-27
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2018-08-27 / Open, Classified

FDA source

Arthrex, Inc. began a recall of 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... on 2018-08-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0295-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-08-27
Posted: 2018-10-30
Recalling firm: Arthrex GmbH
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.
Product code: HAB Saw, Powered, And Accessories
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 root cause: 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 [email protected] 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.
Product codes and lots: UDI Number 0888867223349; Material Number AR-400UBH; Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0295-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0295-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-11-07	2018-10-30

Product code HAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)