Z-0295-2019 Class II Ongoing
FDA device recall Z-0295-2019 was initiated by Arthrex, Inc. on August 27, 2018 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 335 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- August 27, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 335 devices
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.
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.
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.
Code Information
UDI Number 0888867223349; Material Number AR-400UBH; Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435