Arthrex, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0295-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: August 27, 2018

Date Posted: November 7, 2018

Recall Number: Z-0295-2019

Event ID: 81106

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.

Status: Ongoing

Product Quantity: 335 devices

Code Information:

UDI Number 0888867223349; Material Number AR-400UBH; Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435

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.

Voluntary or Mandated:

Voluntary: Firm initiated