Recall Z-0295-2019— Arthrex, Inc.
Class II · Ongoing
Class II FDA medical device recall by Arthrex, Inc., initiated 2018-08-27. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Arthrex, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-08-27
- Firm location
- Naples, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.