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.

Is my product affected?

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.

• UPC 0888867223349

Check against the official notice below — it lists the full affected range.

What happened

The Li-ion Battery Housing for Arthrex's AR-400 DrillSaw Sports 400 System powers the surgical device but may fail to create a complete seal around the battery, potentially allowing fluid to enter the housing. A total of 335 devices with this defective battery housing have been distributed worldwide, including across 20 U.S. states and 20 countries in Europe and the Middle East.

The specific affected devices can be identified by UDI Number 0888867223349, Material Number AR-400UBH, and one of the following batch numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, or GB3854435. The source document does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: 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. Quantity: 335 devices Lot/code info: UDI Number 0888867223349; Material Number AR-400UBH; Batch Numbers: GB4091590, GB4103994, GB4211089, GB4241346, GB4260648, GB4279490, GB4320568, GB4426191, GB3854432, GB3854434, GB3854435

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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