Arthrex Recalls Li-ion Battery Housings for AR-400 DrillSaw Sports 400 System
Arthrex, Inc. is recalling 335 Li-ion Battery Housings for the AR-400 DrillSaw Sports 400 System because they may not provide a complete seal, allowing for potential fluid ingress.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (fluid ingress) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Arthrex, Inc. is recalling 335 Li-ion Battery Housings for the AR-400 DrillSaw Sports 400 System. The product is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
The recall is being conducted because the battery housing may not provide a complete seal around the battery, allowing for potential fluid ingress. The affected units were distributed worldwide, including in the United States and various countries in Europe, Asia, and North America.
Healthcare providers and consumers should stop using the affected battery housings and contact Arthrex, Inc. for further instructions or a replacement. The specific batch numbers and UDI number for the recalled units are listed in the official recall documentation.
The recalled product
- 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.
- Manufacturer
- Arthrex, Inc.
- Hazard
- Affected units
- 335
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- UDI Number 0888867223349
- Material Number AR-400UBH
- Batch Numbers: GB4091590
- GB4103994
- GB4211089
- GB4241346
- GB4260648
- GB4279490
- GB4320568
- GB4426191
- GB3854432
- GB3854434
- GB3854435
Distribution
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