FDA recall Z-2228-2019

Intellijoint Surgical, Inc. · Class II · device

Product

Workstation, G2, Configured (P/N 000-0241)

Reason for recall

Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System.

Distribution

IL, CA, NY, TX, RI, Australia

Key facts

Status
Terminated
Initiation date
2019-06-28
Report date
2019-08-14
Termination date
2020-09-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waterloo, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2228-2019