FDA recall Z-0919-2020
Arthrex, Inc. · Class II · device
Product
Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Reason for recall
There is a potential for blockage of the Hub Attachment Tube.
Distribution
Nationwide in US; no distribution OUS.
Key facts
- Status
- Terminated
- Initiation date
- 2019-12-17
- Report date
- 2020-02-05
- Termination date
- 2023-08-31
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Naples, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0919-2020