FDA Medical Device Recalls (openFDA)
Arthrex, Inc.: 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.
- Recall number
- Z-0295-2019
- Recalling firm
- Arthrex, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2018-08-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- 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 complaints@arthrex.com as soon as possible to arrange for return of affected product.
- Quantity
- 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.
- Lot, serial or model codes
- UDI Number 0888867223349; Material Number AR-400UBH; Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HAB
- Firm FEI
- 1220246
- Firm city
- Naples
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28